The RAPS store will be under maintenance Saturday, 28 September between 6 a.m. and 12 p.m. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.
||Navigating the FDA regulatory process can be challenging. Since 2009 we have advanced the development of over 130 products. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination 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 also provide eCTD publishing services through the ESG.
4851 Tamiami Trail N, Suite 200
Naples, FL 34103
Phone: +1 239 734 3007
President and Principal Consultant