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Driven by a desire to contribute to the advancement of the healthcare industry,
we stand by our clients, offering solutions to a variety of issues they face.
Cues Consulting supports the sustainable growth of our clients through core healthcare industry operations, including Regulatory affairs, CMC regulatory compliance, Pharmacovigilance, Post-marketing surveillance, and Drug pricing strategy, for pharmaceutical companies, biopharmaceuticals, biotech ventures, and startups.
In addition to regulatory affairs services for drug development including Strategy planning, Consultation meeting support, Preparation of application documents, Response to inquiries post-application, and Designation applications for orphan drugs, we also offer comprehensive support for various manufacturing and marketing authorizations, as well as for renewals of such licenses in the pharmaceutical regulation field.
We offer a comprehensive service from CMC application strategy planning during the development phase to post-marketing quality change management, including GMP conformity assessments and foreign manufacturing site certification.
We provide optimal safety management and assurance measures tailored to each product, accurately grasping the safety profile. We support the regular hosting of case review meetings with medical experts, as well as case evaluation and data entry.
Through PharmaLink®*, pharmacists, rigorously trained, carry out a full range of tasks from swift integration to monitoring with precision, enhancing the quality of investigations while achieving expedited processes.
We support pharmaceutical pricing strategies and negotiations, act as domestic managers for clinical trials (ICCC), create various SOPs, assist in obtaining business licenses, and handle mock inspections during license renewal, ensuring both quality and safety. We can also assist in establishing a new reliability assurance department or optimizing your organization, improving your organizational design process through business diagnostics.
Our experienced consultants tailor their consulting to meet your specific needs, proposing solutions to your challenges. We go beyond mere advice, offering hands-on support, including operational outsourcing, to solve your problems effectively.
We deliver customized services tailored to the needs of our clients in the healthcare sector, enhancing their competitive advantage and providing substantial value to their businesses. Our consultants combine the latest medical industry trends with practical experience to formulate optimal strategies, serving as a reliable partner for our clients. Our business analysis and efficiency improvements are based on a deep understanding of our clients’ current situations, offering concrete suggestions for both immediate enhancements and long-term strategic optimization.
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.
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.
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.
For pharmaceuticals, quasi-drugs, and cosmetics, Article 14 of the Pharmaceutical and Medical Device Act (PMD Act) requires that each product must obtain approval from the Minister of Health, Labour and Welfare for manufacturing and marketing. For medical devices and in vitro diagnostic pharmaceuticals, this requirement is outlined in Article 23-2-5 of the same act. There are exemptions to these rules, so for more detailed information, please consult with us.
Using a safety database allows for automatic assignment of MedDRA and drug codes, significantly contributing to the reliability and efficiency of the work. Moreover, when creating periodic reports, data aggregation from the database greatly enhances the reliability of the document submission process to regulatory authorities.
Yes, if the PMDA finds the explanation for the scientific and rational basis insufficient, they may request a reclassification of the change.