Credentials and Achievement

Vast experience of the core members of the RA team for the IND/BLA submissions in the U.S. and China.

IND submissions completed including monoclonal antibodies, bispecific antibodies, and fusion proteins with high concentration and ophthalmic formulations. 

Timely tracking drug regulatory trends and regulatory feedbacks and adjust CMC development strategy.

Services

Our regulatory services include: 

• Draft and review CTD Module 3 and facilitate the responses to CMC questions raised by regulatory agencies. 

• Develop briefing packages and support meetings with regulatory agencies .

• Update CMC filing, submit supplements, and provide support for life cycle management of a product.