Registration and Application Services
We have a dedicated drug regulatory team that offers clients services for clinical trial applications (IND/CTA) at different stages (P1, P2, P3), new drug marketing authorization applications (NDA/MAA), generic drug marketing authorization applications (ANDA), and product marketing maintenance, including services for product changes, annual reports, and re-registration.
Provide synchronous evaluation, planning, and feasibility consultation for CMC (Chemistry, Manufacturing, and Controls) during the R&D process, and offer compliance guidance for production activities.
Prepare, write, and conduct technical reviews of CMC filing materials to ensure that the quality of the submitted documents meets the submission requirements.
Provide customized filing services for customized products of pharmaceutical enterprises.
Offer registration support for pharmaceutical documentation of biological products in relation to NMPA (National Medical Products Administration) IND (Investigational New Drug), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application).
Handle registration applications in the United States, Europe, Japan, WHO (World Health Organization), China, and other countries (such as DMF (Drug Master File), ASMF (Active Substance Master File), CEP (Certificate of Suitability), MF (Manufacturing File), APIMF (Active Pharmaceutical Ingredient Master File), and the registration and filing of active pharmaceutical ingredients, etc.).
Provide Chinese-English translation services for filing materials.
Ensure that the quality of the submitted documents meets the submission requirements.
Submit the materials and promptly follow up, provide feedback.
