Our services

Regulatory Affairs Consulting

Investigational New Drug (IND) Application

Now that you have done all the hard work to develop a new drug product, it is time to have it enter the market so the patients who need it should get it. We have what it takes to assist you to navigate the complex landscape and get approval from the FDA. We are specialized in the IND services below to ensure they meet and exceed the requirements for approval:

 

  • Form FDA 1571 and 3674
  • Table of contents
  • Introductory statement
  • General investigational plan
  • Investigator’s brochure
  • Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB)
  • Chemistry, Manufacturing and Control (CMC) data, including environmental assessment or claim for exclusion (assuming the draft of CMC information exists)
  • Nonclinical: pharmacology and toxicology data
  • Clinical: previous human experience
  • Additional information to support the IND filing

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