DETAILS DESCRIPTION
Regulatory Affairs
- Position :
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
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