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