We have extensive experiences in regulatory affairs for 20 years. We have registered drug products and APIs for internationally renowned pharmaceutical companies. As the regulatory requirements were continuously changing in China, we have helped the companies to adapt to the changing environment in China.

 

Our main regulatory services include:

Assistance in preparation of regulatory documents

Translation and review of regulatory documents

Submission of documents

Responses to deficiency letters (Review Opinions)

Liaison with FDF partners for API applicants

Tracking, liaison and pushing for progresses

Assistance in BE/BA, clinical studies and QCE

Pre-approval application for major amendments

Annual reporting