Case Studies

Case Studies

Our Track Record

Breakdown of Contracted Services by Category & Number of Contracts Related to Rare Disease Services

Common Challenges

Regulatory affairs is a field that requires high-level expertise. At CUES, we support the construction of optimal regulatory strategies according to the development status and challenges of each company.

Limited access to experts
Weak PMDA strategy
Need for EU Pharmacovigilance Expertise
Inefficient safety operations
Unclear pathway to obtaining a Marketing Authorization License
Shortage of specialized talent
Uncertainty in global regulatory strategy

Phases Where We Are Frequently Consulted

Early-Stage Drug Development
Before PMDA consultations
Before approval application
Market entry of overseas companies into Japan
Post-marketing safety management

etc...

Solution Examples

Case List

Regulatory Strategy Support for New Drug Development in Japan

Client	A biotech venture developing a new drug
Challenge	To proceed with new drug development in Japan, the company needs to organize its regulatory strategy from the early development stage with PMDA consultation in mind. However, it is not yet clear how to organize clinical, nonclinical, and CMC data, or which issues should be raised during the regulatory consultation. • The development policy and regulatory strategy for Japan are not yet fully organized • Clinical development plans, nonclinical data, CMC documents, and related materials need to be organized with PMDA consultation in mind • There is uncertainty about the issues to raise in regulatory consultation, response policies for PMDA inquiries, and the structure of consultation materials
Support Details	Support Based on Japanese Regulatory Requirements We conduct gap analysis of the nonclinical and clinical data packages and propose actions based on the results. With PMDA consultation in mind, we support the organization of consultation materials, responses to inquiry points, and response strategies for PMDA comments. Regulatory Consultation Support We support preliminary meetings, formal PMDA consultations, and other regulatory procedures. We support the preparation of consultation materials, responses to PMDA inquiries, and anticipated Q&A. Consultant's Comments Organizing the development policy from the early stage with PMDA consultation in mind is important for efficiently advancing new drug development in Japan. CUES reviews the data package from nonclinical, clinical, and CMC perspectives, and supports issue identification and document preparation for regulatory consultation.

Client

A biotech venture developing a new drug

Challenge

To proceed with new drug development in Japan, the company needs to organize its regulatory strategy from the early development stage with PMDA consultation in mind. However, it is not yet clear how to organize clinical, nonclinical, and CMC data, or which issues should be raised during the regulatory consultation.

• The development policy and regulatory strategy for Japan are not yet fully organized
• Clinical development plans, nonclinical data, CMC documents, and related materials need to be organized with PMDA consultation in mind
• There is uncertainty about the issues to raise in regulatory consultation, response policies for PMDA inquiries, and the structure of consultation materials

Support Details

Support Based on Japanese Regulatory Requirements

We conduct gap analysis of the nonclinical and clinical data packages and propose actions based on the results.
With PMDA consultation in mind, we support the organization of consultation materials, responses to inquiry points, and response strategies for PMDA comments.

Regulatory Consultation Support

We support preliminary meetings, formal PMDA consultations, and other regulatory procedures.
We support the preparation of consultation materials, responses to PMDA inquiries, and anticipated Q&A.

Consultant's Comments

Organizing the development policy from the early stage with PMDA consultation in mind is important for efficiently advancing new drug development in Japan.
CUES reviews the data package from nonclinical, clinical, and CMC perspectives, and supports issue identification and document preparation for regulatory consultation.

Expected Outcomes	Optimization of the Regulatory Strategy in Japan We support the development of a regulatory strategy designed to increase the likelihood of obtaining marketing approval in Japan. From preparation for preliminary meetings and formal PMDA consultation through completion, we support effective discussion based on mutual understanding between the applicant and the regulator. Timely Regulatory Authority Response We support regulatory authority interactions—including applications for preliminary meetings and formal PMDA consultation, and the preparation and submission of consultation materials and responses to inquiry points—so that the process can proceed without delay. Key points of the results In formal PMDA consultations, the applicant must consolidate and submit responses and views on inquiry points and PMDA comments within a limited schedule. CUES establishes the timeline and role assignments in advance and supports proper time management so that responses to the regulator can proceed without delay. We also support smooth and meaningful discussions between the applicant and PMDA, for example by planning rehearsals before preliminary meetings and formal consultations. CUES provides comprehensive development regulatory affairs support to biotech ventures advancing new drug development in Japan, including the optimization of regulatory strategy and related activities for regulatory consultations.

Expected Outcomes

Optimization of the Regulatory Strategy in Japan

We support the development of a regulatory strategy designed to increase the likelihood of obtaining marketing approval in Japan.
From preparation for preliminary meetings and formal PMDA consultation through completion, we support effective discussion based on mutual understanding between the applicant and the regulator.

Timely Regulatory Authority Response

We support regulatory authority interactions—including applications for preliminary meetings and formal PMDA consultation, and the preparation and submission of consultation materials and responses to inquiry points—so that the process can proceed without delay.

Key points of the results

In formal PMDA consultations, the applicant must consolidate and submit responses and views on inquiry points and PMDA comments within a limited schedule.
CUES establishes the timeline and role assignments in advance and supports proper time management so that responses to the regulator can proceed without delay.
We also support smooth and meaningful discussions between the applicant and PMDA, for example by planning rehearsals before preliminary meetings and formal consultations.

CUES provides comprehensive development regulatory affairs support to biotech ventures advancing new drug development in Japan, including the optimization of regulatory strategy and related activities for regulatory consultations.

CMC Regulatory Affairs Support for Pharmaceutical Development Companies

Client	A biotech venture developing a new drug
Challenge	To prepare for a new drug marketing authorization application, the company needs to organize CMC information related to the drug substance, drug product, and manufacturing process as application documents. However, there are challenges in organizing existing data and structuring it as CTD Module 2.3, creating uncertainty about whether the dossier will meet the expectations of the regulator. • CMC data organization is insufficient • Lack of know-how in CTD preparation • Concerns about responding to regulatory requirements
Support Details	CMC Data Organization We organize information on the drug substance, drug product, and manufacturing process and restructure it into a format suitable for application documents. CTD Module2.3 Preparation Support We organize CMC information in CTD format and support the preparation of application documents that can withstand regulatory review. PMDA Inquiry Response Support We analyze the regulator’s questions and support the preparation of response documents based on scientific rationale. Consultant's Comments In CMC, the way data is organized and the logic of the dossier are often more important than the volume of data. CUES supports dossier preparation tailored to the application by making full use of existing data.

Client

A biotech venture developing a new drug

Challenge

To prepare for a new drug marketing authorization application, the company needs to organize CMC information related to the drug substance, drug product, and manufacturing process as application documents. However, there are challenges in organizing existing data and structuring it as CTD Module 2.3, creating uncertainty about whether the dossier will meet the expectations of the regulator.

• CMC data organization is insufficient
• Lack of know-how in CTD preparation
• Concerns about responding to regulatory requirements

Support Details

CMC Data Organization

We organize information on the drug substance, drug product, and manufacturing process and restructure it into a format suitable for application documents.

CTD Module2.3 Preparation Support

We organize CMC information in CTD format and support the preparation of application documents that can withstand regulatory review.

PMDA Inquiry Response Support

We analyze the regulator’s questions and support the preparation of response documents based on scientific rationale.

Consultant's Comments

In CMC, the way data is organized and the logic of the dossier are often more important than the volume of data.
CUES supports dossier preparation tailored to the application by making full use of existing data.

Expected Outcomes	Improved Quality of CMC Documents We support the preparation of CMC application documents at a quality level suitable for regulatory review. Shorter Application Preparation Timeline By organizing existing data and optimizing document structure, we aim to improve the speed of application preparation. More Efficient Regulatory Response We help organize responses to inquiry points and build a framework for smooth review-stage communication. Key points of the results In CMC, simply collecting data is not enough. Consistency of data and a logical document structure are key to responding effectively during review. CUES focuses on organizing existing research data and manufacturing information and restructuring it into a format that is easy for the regulator to understand as application documents. As a result, we aim to build CMC documents that not only improve application preparation efficiency, but also strengthen the ability to respond to regulatory review.

Expected Outcomes

Improved Quality of CMC Documents

We support the preparation of CMC application documents at a quality level suitable for regulatory review.

Shorter Application Preparation Timeline

By organizing existing data and optimizing document structure, we aim to improve the speed of application preparation.

More Efficient Regulatory Response

We help organize responses to inquiry points and build a framework for smooth review-stage communication.

Key points of the results

In CMC, simply collecting data is not enough.
Consistency of data and a logical document structure are key to responding effectively during review.

CUES focuses on organizing existing research data and manufacturing information and restructuring it into a format that is easy for the regulator to understand as application documents.

As a result, we aim to build CMC documents that not only improve application preparation efficiency, but also strengthen the ability to respond to regulatory review.

PMDA Inquiry Response Support after Submission: Nonclinical, Clinical, and Statistical Inquiries

Client	A foreign-affiliated pharmaceutical manufacturer
Challenge	After the marketing authorization application is submitted, PMDA issues many inquiry points, and the company must organize its response strategy within a limited timeframe. The challenge is to accurately understand the intent behind each inquiry and prepare scientifically grounded responses while coordinating with internal and external stakeholders. • The number of post-application inquiries is high, and internal teams cannot keep up • The intent and priority of each inquiry need to be organized • Coordination with stakeholders, including overseas departments, and preparation of response documents take time
Support Details	Inquiry Point Analysis We understand the intent of each question and classify inquiry points by priority. When the intent is unclear, we advise confirming it with PMDA as early as possible. Response Strategy Design We prepare and propose response policies. Response Document Preparation Support We support the preparation of responses based on scientific rationale. We can also support negotiations and coordination with overseas departments when needed. Consultant's Comments PMDA inquiry points are not merely questions; they are important signals of the reviewer’s concerns and are issued with a clear intent regarding the type of response required. Clear communication with the reviewer is essential for prompt responses.

Client

A foreign-affiliated pharmaceutical manufacturer

Challenge

After the marketing authorization application is submitted, PMDA issues many inquiry points, and the company must organize its response strategy within a limited timeframe. The challenge is to accurately understand the intent behind each inquiry and prepare scientifically grounded responses while coordinating with internal and external stakeholders.

• The number of post-application inquiries is high, and internal teams cannot keep up
• The intent and priority of each inquiry need to be organized
• Coordination with stakeholders, including overseas departments, and preparation of response documents take time

Support Details

Inquiry Point Analysis

We understand the intent of each question and classify inquiry points by priority. When the intent is unclear, we advise confirming it with PMDA as early as possible.

Response Strategy Design

We prepare and propose response policies.

Response Document Preparation Support

We support the preparation of responses based on scientific rationale. We can also support negotiations and coordination with overseas departments when needed.

Consultant's Comments

PMDA inquiry points are not merely questions; they are important signals of the reviewer’s concerns and are issued with a clear intent regarding the type of response required.
Clear communication with the reviewer is essential for prompt responses.

Expected Outcomes	Prompt Submission of Responses We organize the issues behind the inquiry points and support efficient response preparation. More Efficient Review Response We organize communication with the regulator and aim to facilitate a smooth review process. Improved Quality of Application Documents We improve the quality of review responses by strengthening the scientific rationale of the answers and consistency across responses. Key points of the results PMDA inquiry points are important messages that indicate the reviewer’s concerns, not just simple questions. Accurately understanding the intent of each inquiry and building a strategic response is key to successful review-stage communication. Communication with reviewers itself is also important, and CUES provides support in this area as well.

Expected Outcomes

Prompt Submission of Responses

We organize the issues behind the inquiry points and support efficient response preparation.

More Efficient Review Response

We organize communication with the regulator and aim to facilitate a smooth review process.

Improved Quality of Application Documents

We improve the quality of review responses by strengthening the scientific rationale of the answers and consistency across responses.

Key points of the results

PMDA inquiry points are important messages that indicate the reviewer’s concerns, not just simple questions.
Accurately understanding the intent of each inquiry and building a strategic response is key to successful review-stage communication.
Communication with reviewers itself is also important, and CUES provides support in this area as well.

MAH System Development for Domestic Companies (GVP/GQP Systems)

Client	A domestic company developing a new drug
Challenge	To obtain a pharmaceutical Marketing Authorization Holder (MAH) license in Japan, the company needs to establish a system capable of appropriately conducting post-marketing safety management and quality management. The challenge is how to build SOPs, roles and responsibilities, and an operating framework that complies with GVP/GQP ordinances. • Post-marketing safety management and quality management systems for obtaining a pharmaceutical MAH license in Japan are not yet established • SOPs, roles and responsibilities, and operating systems compliant with GVP/GQP ordinances need to be developed
Support Details	GVP/GQP System Design We support the design of post-marketing safety management and quality management systems. Safety Management SOP / Quality Management SOP Preparation We support the development of the required SOPs. Internal Training We provide training related to safety management and quality management operations. Mock Inspection for MAH Licensing We conduct mock inspections before the regulatory authority inspection. Consultant's Comments Post-marketing safety management and quality management are critical functions directly linked to corporate reliability.

Client

A domestic company developing a new drug

Challenge

To obtain a pharmaceutical Marketing Authorization Holder (MAH) license in Japan, the company needs to establish a system capable of appropriately conducting post-marketing safety management and quality management. The challenge is how to build SOPs, roles and responsibilities, and an operating framework that complies with GVP/GQP ordinances.

• Post-marketing safety management and quality management systems for obtaining a pharmaceutical MAH license in Japan are not yet established
• SOPs, roles and responsibilities, and operating systems compliant with GVP/GQP ordinances need to be developed

Support Details

GVP/GQP System Design

We support the design of post-marketing safety management and quality management systems.

Safety Management SOP / Quality Management SOP Preparation

We support the development of the required SOPs.

Internal Training

We provide training related to safety management and quality management operations.

Mock Inspection for MAH Licensing

We conduct mock inspections before the regulatory authority inspection.

Consultant's Comments

Post-marketing safety management and quality management are critical functions directly linked to corporate reliability.

Expected Outcomes	Establishment of Safety Management and Quality Management Systems We support the development of GVP/GQP systems compliant with the Pharmaceuticals and Medical Devices Act. Strengthened Regulatory Readiness We help build a framework that enables appropriate implementation of post-marketing safety management and quality management operations. Sustainable Safety Management and Quality Management We develop training and operating frameworks to establish systems that can be run continuously. Key points of the results Post-marketing safety management and quality management for pharmaceuticals are critical functions directly connected to a company’s social responsibility. CUES supports not only regulatory compliance, but also the development of safety management and quality management systems that companies can operate sustainably.

Expected Outcomes

Establishment of Safety Management and Quality Management Systems

We support the development of GVP/GQP systems compliant with the Pharmaceuticals and Medical Devices Act.

Strengthened Regulatory Readiness

We help build a framework that enables appropriate implementation of post-marketing safety management and quality management operations.

Sustainable Safety Management and Quality Management

We develop training and operating frameworks to establish systems that can be run continuously.

Key points of the results

Post-marketing safety management and quality management for pharmaceuticals are critical functions directly connected to a company’s social responsibility.
CUES supports not only regulatory compliance, but also the development of safety management and quality management systems that companies can operate sustainably.

Strengthening Audit Readiness by Revising SOPs and Records

Client	A domestic pharmaceutical company
Challenge	Day-to-day operations are moving forward, but when preparing for audits and inspections, the SOPs and records do not sufficiently demonstrate the appropriateness of operations. The company needs to review consistency across documents and the way records are maintained in order to strengthen the explanatory power of the overall system. • There are issues with consistency across documents and how records are maintained • Actual operations are not fully aligned with SOPs and records • The system needs to be organized so that operations and controls can be explained clearly during audits and inspections
Support Details	Gap Analysis We compare current operations with applicable requirements and clarify the areas that require improvement. Reorganization of the Document Structure We review consistency between SOPs and related record forms and redesign the document structure so it is easier to use in practice. Alignment of Operations and Documents We resolve discrepancies between actual operations and document content, and establish an operating framework that can be clearly explained. Review of Quality Management Operations We review the operation of training records, deviation management, and CAPA management to support continuous improvement. Improvement Plan Development We develop a practical improvement plan with priorities organized in anticipation of possible audit findings.

Client

A domestic pharmaceutical company

Challenge

Day-to-day operations are moving forward, but when preparing for audits and inspections, the SOPs and records do not sufficiently demonstrate the appropriateness of operations. The company needs to review consistency across documents and the way records are maintained in order to strengthen the explanatory power of the overall system.

• There are issues with consistency across documents and how records are maintained
• Actual operations are not fully aligned with SOPs and records
• The system needs to be organized so that operations and controls can be explained clearly during audits and inspections

Support Details

Gap Analysis

We compare current operations with applicable requirements and clarify the areas that require improvement.

Reorganization of the Document Structure

We review consistency between SOPs and related record forms and redesign the document structure so it is easier to use in practice.

Alignment of Operations and Documents

We resolve discrepancies between actual operations and document content, and establish an operating framework that can be clearly explained.

Review of Quality Management Operations

We review the operation of training records, deviation management, and CAPA management to support continuous improvement.

Improvement Plan Development

We develop a practical improvement plan with priorities organized in anticipation of possible audit findings.

Expected Outcomes	Improved Consistency By aligning the document structure with actual operations, we help realize a consistent management system. Stronger Explainability We clarify the rationale for systems and operations, making them easier to explain during audits and inspections. Reduced Risk of Findings By identifying and correcting issues in advance, we help reduce the risk of findings during audits and inspections. Establishment of a Continuous Improvement Framework We strengthen collaboration with quality assurance teams and support the development of a framework for continuously improving operational quality. Key points of the results By developing documents and records rooted in actual operations, we improve the PV system into one with stronger audit readiness.

Expected Outcomes

Improved Consistency

By aligning the document structure with actual operations, we help realize a consistent management system.

Stronger Explainability

We clarify the rationale for systems and operations, making them easier to explain during audits and inspections.

Reduced Risk of Findings

By identifying and correcting issues in advance, we help reduce the risk of findings during audits and inspections.

Establishment of a Continuous Improvement Framework

We strengthen collaboration with quality assurance teams and support the development of a framework for continuously improving operational quality.

Key points of the results

By developing documents and records rooted in actual operations, we improve the PV system into one with stronger audit readiness.

Drug Pricing Strategy Support in Early-Stage Development

Client	A biotech venture developing a new drug
Challenge	From the early stage of development, the company needs to organize product value and clinical positioning with future NHI price listing in mind. However, the potential comparators, pricing calculation method, and possibility of premiums have not yet been sufficiently examined, and the direction of the pricing strategy is not clear. • In the early stage of development in Japan, sufficient consideration has not yet been given to future NHI price listing • The pricing strategy needs to be organized based on potential comparator drugs, pricing calculation methods, and the possibility of premiums • The product value and clinical positioning that could support pricing evaluation are unclear
Support Details	Identification of Pricing Issues We organize the target disease, existing therapies, potential comparator drugs, presence or absence of similar drugs, and other factors, and examine issues expected in Japan’s drug pricing process. Initial Design of Drug Pricing Strategy Based on possible pricing calculation methods, the likelihood of premiums, and the relationship with foreign prices, we organize pricing strategy considerations for the early development stage. Organization of Product Value We clarify product value that may support pricing evaluation from perspectives such as efficacy, safety, target patients, differentiation from existing therapies, and medical usefulness. Document Preparation with Future NHI Price Listing in Mind We support early organization of product value, differentiation from existing therapies, and clinical positioning that will need to be explained during price calculation. Consultant's Comments Drug pricing strategy should not be considered only after approval. It is important to start considering future NHI price listing from the early stage of development. CUES supports the development of a pricing strategy for launch in Japan by identifying potential pricing issues and product value early.

Client

A biotech venture developing a new drug

Challenge

From the early stage of development, the company needs to organize product value and clinical positioning with future NHI price listing in mind. However, the potential comparators, pricing calculation method, and possibility of premiums have not yet been sufficiently examined, and the direction of the pricing strategy is not clear.

• In the early stage of development in Japan, sufficient consideration has not yet been given to future NHI price listing
• The pricing strategy needs to be organized based on potential comparator drugs, pricing calculation methods, and the possibility of premiums
• The product value and clinical positioning that could support pricing evaluation are unclear

Support Details

Identification of Pricing Issues

We organize the target disease, existing therapies, potential comparator drugs, presence or absence of similar drugs, and other factors, and examine issues expected in Japan’s drug pricing process.

Initial Design of Drug Pricing Strategy

Based on possible pricing calculation methods, the likelihood of premiums, and the relationship with foreign prices, we organize pricing strategy considerations for the early development stage.

Organization of Product Value

We clarify product value that may support pricing evaluation from perspectives such as efficacy, safety, target patients, differentiation from existing therapies, and medical usefulness.

Document Preparation with Future NHI Price Listing in Mind

We support early organization of product value, differentiation from existing therapies, and clinical positioning that will need to be explained during price calculation.

Consultant's Comments

Drug pricing strategy should not be considered only after approval. It is important to start considering future NHI price listing from the early stage of development.
CUES supports the development of a pricing strategy for launch in Japan by identifying potential pricing issues and product value early.

Expected Outcomes	Clarification of Pricing Issues We organize potential comparator drugs, pricing calculation methods, the possibility of premiums, and other factors to clarify issues to be addressed for future NHI price listing. Organization of Product Value We clarify clinical usefulness, differentiation from existing therapies, and clinical positioning that may support pricing evaluation. Pricing Strategy Consideration from Early Development By considering NHI price listing from the early stage of development, we support preparation for launch in Japan. Key points of the results Pharmaceutical pricing is affected not only by post-approval procedures, but also by data accumulated during development, potential comparator drugs, target patients, and medical usefulness. CUES supports strategy development for future NHI price listing by considering pricing evaluation from the early stage of development.

Expected Outcomes

Clarification of Pricing Issues

We organize potential comparator drugs, pricing calculation methods, the possibility of premiums, and other factors to clarify issues to be addressed for future NHI price listing.

Organization of Product Value

We clarify clinical usefulness, differentiation from existing therapies, and clinical positioning that may support pricing evaluation.

Pricing Strategy Consideration from Early Development

By considering NHI price listing from the early stage of development, we support preparation for launch in Japan.

Key points of the results

Pharmaceutical pricing is affected not only by post-approval procedures, but also by data accumulated during development, potential comparator drugs, target patients, and medical usefulness.
CUES supports strategy development for future NHI price listing by considering pricing evaluation from the early stage of development.

Mock Inspection and Improvement Support for License Renewal

Client	A pharmaceutical company preparing to renew its pharmaceutical MAH license
Challenge	Before renewing its pharmaceutical MAH license, the company needs to confirm the status of internal systems, SOPs, and records in advance of the regulatory inspection. The challenge is to understand whether actual operations are conducted in accordance with SOPs and whether any points need improvement before the inspection. • The company wants to confirm the status of internal systems, SOPs, and records in advance of MAH license renewal • There are concerns about whether quality management and safety management operations are being conducted according to SOPs • Issues must be identified and necessary improvements completed before the regulatory inspection
Support Details	Current State Assessment We review organizational structures, SOPs, records, business workflows, and other items related to quality management and safety management, and organize points to confirm for license renewal. Mock Inspection Assuming a regulatory inspection, we conduct interviews with relevant personnel, review SOPs and records, and confirm operational status. Identification of Issues and Improvement Items Based on the findings, we organize inconsistencies between SOPs and actual operations, missing records, unclear role assignments, and other issues. Improvement Support We support SOP revisions, record development, internal explanatory materials, and other actions required for license renewal. Consultant's Comments At the time of license renewal, it is important not only to have SOPs in place, but also to ensure that actual operations are appropriately conducted in line with those procedures. Through mock inspections, CUES clarifies current issues and supports the improvement actions needed before the regulatory inspection.

Client

A pharmaceutical company preparing to renew its pharmaceutical MAH license

Challenge

Before renewing its pharmaceutical MAH license, the company needs to confirm the status of internal systems, SOPs, and records in advance of the regulatory inspection. The challenge is to understand whether actual operations are conducted in accordance with SOPs and whether any points need improvement before the inspection.

• The company wants to confirm the status of internal systems, SOPs, and records in advance of MAH license renewal
• There are concerns about whether quality management and safety management operations are being conducted according to SOPs
• Issues must be identified and necessary improvements completed before the regulatory inspection

Support Details

Current State Assessment

We review organizational structures, SOPs, records, business workflows, and other items related to quality management and safety management, and organize points to confirm for license renewal.

Mock Inspection

Assuming a regulatory inspection, we conduct interviews with relevant personnel, review SOPs and records, and confirm operational status.

Identification of Issues and Improvement Items

Based on the findings, we organize inconsistencies between SOPs and actual operations, missing records, unclear role assignments, and other issues.

Improvement Support

We support SOP revisions, record development, internal explanatory materials, and other actions required for license renewal.

Consultant's Comments

At the time of license renewal, it is important not only to have SOPs in place, but also to ensure that actual operations are appropriately conducted in line with those procedures.
Through mock inspections, CUES clarifies current issues and supports the improvement actions needed before the regulatory inspection.

Expected Outcomes	Clarification of Issues for License Renewal We review SOPs, records, and operational status to organize items that should be addressed before the regulatory inspection. Improvement of SOPs and Records We support the review of SOPs and records based on actual operations, helping strengthen internal systems. Stronger Preparation for the Regulatory Inspection Through mock inspections, we organize expected confirmation points and explanations in advance, supporting preparation for the regulatory inspection. Key points of the results Preparation for license renewal requires confirming not only the existence of SOPs and records, but also their consistency with actual operations. CUES visualizes current issues through mock inspections and supports improvement actions before the regulatory inspection.

Expected Outcomes

Clarification of Issues for License Renewal

We review SOPs, records, and operational status to organize items that should be addressed before the regulatory inspection.

Improvement of SOPs and Records

We support the review of SOPs and records based on actual operations, helping strengthen internal systems.

Stronger Preparation for the Regulatory Inspection

Through mock inspections, we organize expected confirmation points and explanations in advance, supporting preparation for the regulatory inspection.

Key points of the results

Preparation for license renewal requires confirming not only the existence of SOPs and records, but also their consistency with actual operations.
CUES visualizes current issues through mock inspections and supports improvement actions before the regulatory inspection.

PV/GVP Audit Support

Client	A pharmaceutical company conducting PV/GVP audits of business partners or outsourced service providers
Challenge	When conducting PV/GVP audits of business partners or outsourced service providers, the company must address not only domestic GVP but also overseas regulatory requirements such as EU-GVP. Specialist support is required from audit preparation through audit-day checks, post-audit finding organization, and CAPA review. • PV/GVP audits of business partners or outsourced service providers need to be conducted • Audit responses must take into account overseas regulatory requirements such as EU-GVP, in addition to Japanese GVP • Specialist support is needed for audit preparation, audit-day confirmation points, organization of findings, and post-audit follow-up
Support Details	Audit Preparation Support We support the preparation or review of audit plans, audit agendas, pre-audit questionnaires, lists of requested documents, and related materials. Pre-Audit Document Review We review SOPs, records, contract-related documents, and other materials submitted by the auditee, and organize points to confirm on the audit day. PV/GVP Audit Execution Support Taking into account Japanese GVP and overseas regulatory requirements such as EU-GVP, we support interviews, document review, practical checks as needed, and various audit meetings. Support for Audit Findings and Draft Report Preparation We organize matters identified during the audit and support the classification of findings, improvement recommendations, and preparation of the draft audit report. CAPA Review Support We review CAPA plans or response results submitted by the auditee and support post-audit follow-up. Consultant's Comments In recent years, PV/GVP audits increasingly require risk-based audit responses that take overseas regulatory requirements such as EU-GVP into account, in addition to compliance with domestic GVP. Based on practical experience in safety management and PV/GVP audits, CUES supports audit preparation, audit execution, draft audit report preparation, and CAPA review.

Client

A pharmaceutical company conducting PV/GVP audits of business partners or outsourced service providers

Challenge

When conducting PV/GVP audits of business partners or outsourced service providers, the company must address not only domestic GVP but also overseas regulatory requirements such as EU-GVP. Specialist support is required from audit preparation through audit-day checks, post-audit finding organization, and CAPA review.

• PV/GVP audits of business partners or outsourced service providers need to be conducted
• Audit responses must take into account overseas regulatory requirements such as EU-GVP, in addition to Japanese GVP
• Specialist support is needed for audit preparation, audit-day confirmation points, organization of findings, and post-audit follow-up

Support Details

Audit Preparation Support

We support the preparation or review of audit plans, audit agendas, pre-audit questionnaires, lists of requested documents, and related materials.

Pre-Audit Document Review

We review SOPs, records, contract-related documents, and other materials submitted by the auditee, and organize points to confirm on the audit day.

PV/GVP Audit Execution Support

Taking into account Japanese GVP and overseas regulatory requirements such as EU-GVP, we support interviews, document review, practical checks as needed, and various audit meetings.

Support for Audit Findings and Draft Report Preparation

We organize matters identified during the audit and support the classification of findings, improvement recommendations, and preparation of the draft audit report.

CAPA Review Support

We review CAPA plans or response results submitted by the auditee and support post-audit follow-up.

Consultant's Comments

In recent years, PV/GVP audits increasingly require risk-based audit responses that take overseas regulatory requirements such as EU-GVP into account, in addition to compliance with domestic GVP.
Based on practical experience in safety management and PV/GVP audits, CUES supports audit preparation, audit execution, draft audit report preparation, and CAPA review.

Expected Outcomes	More Efficient Audit Preparation By reviewing documents in advance and organizing confirmation points, we clarify the items that should be checked in depth on the audit day. Audit Execution Considering Overseas Regulatory Requirements In addition to Japanese GVP, we support PV/GVP audits based on risk-based approaches required under EU-GVP and similar frameworks, classification of audit findings by significance, CAPA handling, and related matters. Clearer Post-Audit Follow-Up We organize audit findings, improvement recommendations, and CAPA confirmation items so that post-audit follow-up can proceed appropriately. Key points of the results For PV/GVP audits, it is important to handle audit preparation, audit-day checks, post-audit finding organization, and CAPA review in an integrated manner. CUES supports PV/GVP audits of business partners or outsourced service providers based on Japanese GVP and overseas regulatory requirements such as EU-GVP.

Expected Outcomes

More Efficient Audit Preparation

By reviewing documents in advance and organizing confirmation points, we clarify the items that should be checked in depth on the audit day.

Audit Execution Considering Overseas Regulatory Requirements

In addition to Japanese GVP, we support PV/GVP audits based on risk-based approaches required under EU-GVP and similar frameworks, classification of audit findings by significance, CAPA handling, and related matters.

Clearer Post-Audit Follow-Up

We organize audit findings, improvement recommendations, and CAPA confirmation items so that post-audit follow-up can proceed appropriately.

Key points of the results

For PV/GVP audits, it is important to handle audit preparation, audit-day checks, post-audit finding organization, and CAPA review in an integrated manner.
CUES supports PV/GVP audits of business partners or outsourced service providers based on Japanese GVP and overseas regulatory requirements such as EU-GVP.

Expert Consultation Support Through Monthly Ad Hoc Consulting

Client	A pharmaceutical company or biotech venture with limited in-house specialist resources
Challenge	Consultation needs related to regulatory affairs, CMC regulatory affairs, safety management, and related areas can arise suddenly in daily operations. At the same time, they often do not justify a continuous large-scale project, creating a need for a flexible support structure that allows companies to consult an expert when needed. • When issues related to regulatory affairs, CMC regulatory affairs, safety management, and related areas arise, it is difficult to make decisions internally alone • The company wants to consult an expert, but the issue does not necessarily require a continuous large-scale project • Within a limited budget, the company wants flexible access to specialist support when needed
Support Details	Monthly Ad Hoc Consultation Within the contracted monthly hours, we respond to consultation matters related to regulatory affairs, CMC regulatory affairs, safety management, and other areas. Depending on the topic, we provide advice, document review, policy organization, and related support. Practical Support Tailored to the Issue We provide practical support as needed for regulatory authority interactions, internal procedures, development policy, CMC regulatory affairs, safety management operations, and other matters. Ongoing Support by Project When a specific issue or project arises, we provide continuous support including progress management, document preparation, and coordination among stakeholders. Internal Education and Training Support To enhance internal knowledge and understanding of operations, we prepare training materials by topic and can serve as lecturers for internal training sessions. Consultant's Comments Specialized consultation needs can arise suddenly in daily operations. Through monthly ad hoc consulting, CUES provides flexible support tailored to each company’s situation and budget, enabling companies to consult within the necessary scope when needed.

Client

A pharmaceutical company or biotech venture with limited in-house specialist resources

Challenge

Consultation needs related to regulatory affairs, CMC regulatory affairs, safety management, and related areas can arise suddenly in daily operations. At the same time, they often do not justify a continuous large-scale project, creating a need for a flexible support structure that allows companies to consult an expert when needed.

• When issues related to regulatory affairs, CMC regulatory affairs, safety management, and related areas arise, it is difficult to make decisions internally alone
• The company wants to consult an expert, but the issue does not necessarily require a continuous large-scale project
• Within a limited budget, the company wants flexible access to specialist support when needed

Support Details

Monthly Ad Hoc Consultation

Within the contracted monthly hours, we respond to consultation matters related to regulatory affairs, CMC regulatory affairs, safety management, and other areas. Depending on the topic, we provide advice, document review, policy organization, and related support.

Practical Support Tailored to the Issue

We provide practical support as needed for regulatory authority interactions, internal procedures, development policy, CMC regulatory affairs, safety management operations, and other matters.

Ongoing Support by Project

When a specific issue or project arises, we provide continuous support including progress management, document preparation, and coordination among stakeholders.

Internal Education and Training Support

To enhance internal knowledge and understanding of operations, we prepare training materials by topic and can serve as lecturers for internal training sessions.

Consultant's Comments

Specialized consultation needs can arise suddenly in daily operations.
Through monthly ad hoc consulting, CUES provides flexible support tailored to each company’s situation and budget, enabling companies to consult within the necessary scope when needed.

Expected Outcomes	Specialist Support When Needed We build a structure that allows companies to consult experts by the hour when a consultation matter arises. Flexible Support Design Based on Budget By adjusting monthly consultation hours and scope of support, we provide support tailored to each company’s budget and issues. Support for Internal Decision-Making and Operations By providing advice and document review from a specialist perspective, we support internal decision-making and operational execution. Key points of the results Monthly ad hoc consulting allows companies to receive specialist advice and practical support within the required scope when consultation needs arise. CUES provides flexible support based on each company’s issues and budget, including hourly consultation, project-based hands-on support, and internal education.

Expected Outcomes

Specialist Support When Needed

We build a structure that allows companies to consult experts by the hour when a consultation matter arises.

Flexible Support Design Based on Budget

By adjusting monthly consultation hours and scope of support, we provide support tailored to each company’s budget and issues.

Support for Internal Decision-Making and Operations

By providing advice and document review from a specialist perspective, we support internal decision-making and operational execution.

Key points of the results

Monthly ad hoc consulting allows companies to receive specialist advice and practical support within the required scope when consultation needs arise.
CUES provides flexible support based on each company’s issues and budget, including hourly consultation, project-based hands-on support, and internal education.

Business Analysis and Improvement Support for Reliability Assurance Departments

Client	A pharmaceutical company considering operational improvements for its reliability assurance department
Challenge	For reliability assurance operations such as quality assurance, safety management, and regulatory affairs, the company does not have sufficient visibility into the actual work performed, the division of roles and responsibilities, or how external partners are being managed and coordinated. As a result, it needs to clarify department-wide issues and identify the areas that should be improved. Some operations have been continued for many years, and the company also needs to reassess whether they are still necessary and whether the current methods remain appropriate in light of the present product portfolio and business environment. The review must take into account workload, regulatory necessity, risk, and cost. • The work performed by each department and person, the workload, and the division of roles are not clearly defined • There are gaps between the activities described in SOPs and actual day-to-day operations • There is room to improve the management, evaluation, and auditing of external partners and outsourced vendors • Systems are not being fully utilized, resulting in manual work and duplicated tasks • Management and frontline teams have different perceptions of issues and expectations • The organization faces challenges related to structure, talent development, and business continuity
Support Details	Interviews with Management and Stakeholders We conduct interviews with management, the target department, and related departments to confirm the expected role of the department, actual day-to-day operations, perceptions of issues, and collaboration with other departments. Analysis of Operations and Workload We review the work performed by each person, role allocation, scope of outsourced activities, workload, deliverables, and related matters, then visualize the overall departmental workflow and workload. Review of SOPs and Related Documents We review SOPs and other related documents, and analyze their consistency with regulatory requirements, actual operations, and the current business environment. Identification of Issues and Risks We identify issues from the perspectives of organizational structure, roles, leadership, communication, productivity, and compliance, then assess the business impact and urgency of each issue. Development of an Improvement Policy We propose improvements related to reviewing unnecessary or duplicated work, system utilization, external partner management, organizational structure, and talent development, and clarify the items that should be addressed first. Improvement Workshop We share the analysis results with management and relevant stakeholders, and discuss improvement measures, priorities, and next actions. Consultant's Comments For operational improvement, it is important not only to reduce workload, but also to review role allocation, business processes, outsourcing, and system utilization while reliably maintaining activities that are required from a regulatory perspective. CUES confirms the actual operational situation from both management and frontline perspectives, and supports the development of actionable improvement policies from the viewpoints of regulatory requirements, risk, productivity, and organizational management.

Client

A pharmaceutical company considering operational improvements for its reliability assurance department

Challenge

For reliability assurance operations such as quality assurance, safety management, and regulatory affairs, the company does not have sufficient visibility into the actual work performed, the division of roles and responsibilities, or how external partners are being managed and coordinated. As a result, it needs to clarify department-wide issues and identify the areas that should be improved.

Some operations have been continued for many years, and the company also needs to reassess whether they are still necessary and whether the current methods remain appropriate in light of the present product portfolio and business environment. The review must take into account workload, regulatory necessity, risk, and cost.

• The work performed by each department and person, the workload, and the division of roles are not clearly defined
• There are gaps between the activities described in SOPs and actual day-to-day operations
• There is room to improve the management, evaluation, and auditing of external partners and outsourced vendors
• Systems are not being fully utilized, resulting in manual work and duplicated tasks
• Management and frontline teams have different perceptions of issues and expectations
• The organization faces challenges related to structure, talent development, and business continuity

Support Details

Interviews with Management and Stakeholders

We conduct interviews with management, the target department, and related departments to confirm the expected role of the department, actual day-to-day operations, perceptions of issues, and collaboration with other departments.

Analysis of Operations and Workload

We review the work performed by each person, role allocation, scope of outsourced activities, workload, deliverables, and related matters, then visualize the overall departmental workflow and workload.

Review of SOPs and Related Documents

We review SOPs and other related documents, and analyze their consistency with regulatory requirements, actual operations, and the current business environment.

Identification of Issues and Risks

We identify issues from the perspectives of organizational structure, roles, leadership, communication, productivity, and compliance, then assess the business impact and urgency of each issue.

Development of an Improvement Policy

We propose improvements related to reviewing unnecessary or duplicated work, system utilization, external partner management, organizational structure, and talent development, and clarify the items that should be addressed first.

Improvement Workshop

We share the analysis results with management and relevant stakeholders, and discuss improvement measures, priorities, and next actions.

Consultant's Comments

For operational improvement, it is important not only to reduce workload, but also to review role allocation, business processes, outsourcing, and system utilization while reliably maintaining activities that are required from a regulatory perspective.

CUES confirms the actual operational situation from both management and frontline perspectives, and supports the development of actionable improvement policies from the viewpoints of regulatory requirements, risk, productivity, and organizational management.

Expected Outcomes	Visualization of Department-Wide Operations Through interviews, document review, and operational analysis, we clarify the work performed by each department, the division of roles, workload, and relationships among departments. Clarification of Priority Issues We evaluate the identified issues in terms of business impact and urgency, then present them in priority order. Direction for Operational Efficiency Improvements We present improvement directions that can enhance productivity, such as reducing manual work, utilizing system functions, reviewing unnecessary or duplicated tasks, and optimizing outsourced operations. Clarification of Organizational and Human Resource Issues We clarify items that should be considered for the future, including role allocation, management structure, development of specialist talent, successor planning, and business continuity. Concrete Actions for Improvement Through discussions with management and relevant stakeholders, we separate short-term actions from medium- to long-term items and present an improvement policy that leads to the next actions. Key points of the results Reliability assurance operations need to be reviewed continuously not only for compliance with laws, regulations, and SOPs, but also in line with business scale, product characteristics, organizational structure, and available systems. CUES analyzes actual operations from multiple perspectives and supports the development of improvement policies that maintain regulatory compliance while improving operational efficiency, organizational management, and business continuity.

Expected Outcomes

Visualization of Department-Wide Operations

Through interviews, document review, and operational analysis, we clarify the work performed by each department, the division of roles, workload, and relationships among departments.

Clarification of Priority Issues

We evaluate the identified issues in terms of business impact and urgency, then present them in priority order.

Direction for Operational Efficiency Improvements

We present improvement directions that can enhance productivity, such as reducing manual work, utilizing system functions, reviewing unnecessary or duplicated tasks, and optimizing outsourced operations.

Clarification of Organizational and Human Resource Issues

We clarify items that should be considered for the future, including role allocation, management structure, development of specialist talent, successor planning, and business continuity.

Concrete Actions for Improvement

Through discussions with management and relevant stakeholders, we separate short-term actions from medium- to long-term items and present an improvement policy that leads to the next actions.

Key points of the results

Reliability assurance operations need to be reviewed continuously not only for compliance with laws, regulations, and SOPs, but also in line with business scale, product characteristics, organizational structure, and available systems.

CUES analyzes actual operations from multiple perspectives and supports the development of improvement policies that maintain regulatory compliance while improving operational efficiency, organizational management, and business continuity.

Client Testimonials

From a foreign pharmaceutical company

We were able to reduce costs compared to hiring new personnel

We reached out due to a vacancy in our safety management staff. With a small team and increasingly stringent regulatory requirements, we were at a point where we needed to consider future strategies. Receiving consulting from CUES Consulting not only addressed our staffing issues but also provided clear solutions and identified other areas for improvement. Now, the quality of our safety management tasks has improved, and our global operations have become smoother.

From a domestic pharmaceutical company

We eliminated unnecessary tasks by implementing a safety database.

We thought that only large companies could afford to implement a safety database, but we were surprised to find it within an affordable price range. The introduction of the database has streamlined our workflow, allowing our employees to focus on core tasks. Now, overtime has decreased, and the burden of labor management has been reduced.

From a venture company

Our vague concerns about change management were clearly resolved.

We received support for our business license application to the prefectural government, including advice on responding to inquiries, which allowed us to obtain the license smoothly. Post-marketing, they helped organize our change management process, which is crucial to avoid product shortages, allowing us to continue our business with peace of mind. Throughout the entire process, we appreciated the detailed and careful attention to even the smallest matters.

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