FDA Counsel or Consultant – LA

A client is looking for a FDA consultant to assist with taking a molecule through the medical food regulatory pathway. The Molecule is Sulfo-N-Succinimidyl Oleate. Client also requests assistance finalizing a clean room in their manufacturing facility and registering it as a 503B nonsterile compound pharmacy. Current manufacturing facility operated under cGMP guidelines and would utilize the same SOP's, quality controls and cGMP processes. Client looking for guidelines on how to navigate the process smoothly and efficiently. Please email referrals to jsahagian@reliancelawgroup.com.