FDA Medical Foods Consulting

dicentra offers a key service in Medical Foods Consulting, these products have very specific regulatory requirements, as set forth in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))

Our services in Medical Foods Consulting include:

  • Reviewing the product for compliance with the specific requirements for qualification as a medical food
  • Advise on product labeling and claims
  • Assist with cGMP compliance

dicentra’s team of scientific experts is willing and able to assist you with any questions you may have regarding Medical Foods.