We have a dedicated regulatory affairs team to ensure the regulatory compliance of your projects. Team members are trained in areas of R&D, GMP compliance, and registration, with 50+ DMF, ANDA, IND and NDA submission and approval experiences, covering 10+ markets including China, US, EU, Japan, etc.
? Original submission: preparation and submission of registration dossiers and related documents for API intermediate, API and drug products
? Reply to the deficiency letter: preparation and submission of response to the deficiency letter from agencies
? E-CTD formats and submission, if required
? Post registration dossiers maintenance: amendment and annual report submission, and any other communication needed during a product life-cycle