Drug registration support
Our group has many years of experience in drug registration, as well as is well versed in domestic and international regulations. We can provide strategic consulting, related guidance, and support services for IND, CTA, MAA, NDA and ANDA drug registration application. We can write CTD/eCTD registration filings and review documents to meet CDE, FDA and EMA filing requirements according to client's needs.
- ● One-stop CMC filing dossier preparation service
- ● IND/CTA/BLA/MAA/NDA/DMF Submission Module 2 - Pharmacy Summary & Complete Module 3 Documentation and review
- ● Flexible and customized documentation preparation services
- ● Professional and timely response to authority’s questions
- ● Support and preparation of communication meetings with the authorities
- ● Updates to the application files, supplementary applications, and support after product approval
