Regulatory Affairs

Our Team offers CMC documentation support for IND, CTA, MAA, NDA and ANDA applications in western countries and China. Our highly experienced team works to prepare Module 2 and Module 3 of your regulatory dossier through forward-looking gap analysis and meticulous preparation of source documents. Our dedicated team can add tremendous value to your development program and speed time to market.

Services scope:

◆CMC dossier preparation and technical review(IND/CTA/NDA for USA, Europe and China）

◆Consultation to evaluate strategy, planning and feasibility by staying abreast with key CMC activities, suggestion of any regulatory contribution

◆Gap analysis to evaluate documentation needs for filing readiness

◆Ensure that quality of source documents are ready for regulatory submission

◆Support to fill any gaps through our R & D and CMC platform

◆Translation of written English documents to Chinese or vice versa (e.a.,CMC dossier,technical documents) to different filing purpose