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Regulatory Affairs Services

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