SHINING DATA

We are a bouquet FDA biologics and small molecule consulting group specializing in biologics, biosimilars, and small molecule novel products. Our ex-FDA knowledge gives us a unique strength in understanding these complex requirements to guide your biologic to FDA approval. Our insight gained from developing biologics and gaining approval while working in the pharmaceutical industry allows us to understand regulatory issues from the other side to find solutions to regulatory hurdles. We work as a team partnering with our client and FDA colleagues to meet your commercial goals... We have been working with the world famous bio companies and proudly provided successful solutions during all these years, especially during COVID-19... We have been working in this area for over 20 years, our consultants and founder had been working for FDA for many years before create this company, we have many satisfied clients in Asia, and the U.S.

Also known as: Shining Data LLC

Primary location: San Jose United States