At CUES Consulting,
we offer consulting and
outsourcing services leveraging our
extensive experience in the fields of pharmaceuticals,
including rare diseases,
and regenerative medicine.

At CUES Consulting, we offer consulting and outsourcing services leveraging our extensive experience in the fields of pharmaceuticals, including rare diseases, and regenerative medicine.
If you are facing challenges like these, please consult with us

If you are facing challenges like these, please consult with us

  • Wanting to consult with various experts as needed.
  • Lacking professional skills and knowledge in negotiation strategies with the PMDA.
  • Unsure how to proceed with post-marketing change management without a CMC expert.
  • Struggling to improve productivity and quality in safety operations.
  • Needing to know what and when to prepare for obtaining a manufacturing and marketing business license.
  • Searching for an outsourcing partner for post-marketing surveillance.
  • Considering international expansion and seeking advice on development strategies and regulatory approval overseas.

What We Can Do

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.

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.

Specialized Consulting for Comprehensive Business Support

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.

Achievements & Client Testimonials


FAQs

What requires approval for marketing authorization and what does not?

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.

What are the benefits of using a safety database?

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.

Can a minor change be asked to be classified as a partial change by the PMDA?

Yes, if the PMDA finds the explanation for the scientific and rational basis insufficient, they may request a reclassification of the change.