Supporting Development Strategies
CMIC Groups’ CMC Consulting team supports our customers with evaluation of CMC data through Gap-Analysis for conducting clinical trials in Japan (CTN) and/or New Drug Application (J-NDA) filings in Japan. Our consultants are able to make suggestions/recommendations on additional tests or data that is required in CTN or J-NDA.
Our Edge in CMC Consulting
Accumulated Knowledge and Know-How for Regulatory Requirements
- Timely provision of high-quality data based on our wealth of knowledge and experience. With our broad experience in CTD preparation for various kinds of drugs, such as low molecule, biopharmaceuticals (including biosimilar and bio-products derived from plasma), we can prepare high-quality CTD (M2.3 and M1.2) in Japanese based on the corresponding global CTD M3. We can support the Japanese specific requirements for J-NDA filing and propose modifications based on Pharmacopeia differences and other challenges (e.g., non-harmonized monographs, general test methods and general rules). We also have the experience to prepare simplified method descriptions. Additionally, our CMC experts can advise you on how to respond to PMDA, considering both your investigational products’ needs and Japanese requirements.
- After NDA filing, CMIC group can support and lead GMP inspection for documentation, submission and responding to inquiries, standing in for our foreign clients. Supporting GMP inspection is available at document inspection. We can also support periodic inspection every 5 years.
Drug Development Support
- Our team supports management of manufacturing methods for active pharmaceutical ingredients (API) and drug products (DP), including specifications and test method, stability testing and analytical validation based on the Japanese Pharmacopeias in the development stage before J-NDA filing. We support establishment of the manufacturing process for low molecule, nucleotide/peptide, and protein products, ensuring compliance with GMP. We also set standards for bio-derived raw materials, management of impurities and virus removal according to ICH guidelines and Japanese specific requirements. Our consultants are prepared to respond to new raw material technologies, increasing our speed and precision in supporting development.
- Preparation of Common Technical Documents (J-CTD)
- Preparation of responses for PMDA inquiries after J-NDA submission
- Drug Master File (J-DMF) registration and maintenance
- Registration and maintenance for Foreign Manufacturing Accreditation
- Preparation of documents for GMP inspections
- Attending PMDA meetings (formal and informal)