cmc regulatory

Pre-IND Meetings, Preparation and Review of Regulatory Submissions


PRE-IND MEETING requests; Pre-ind briefing books

Prior to initiating a clinical trial for a new drug, questions of a scientific and regulatory nature may come up that require a discussion with a regulatory agency:

  • Are the drug substance specifications for your new drug too broad, too narrow, sufficient?

  • Will the Regulatory Agency accept your 1-month stability data for a nonGMP demo batch of drug substance, instead of stability data for your GMP batch?

  • Will the Regulatory Agency accept that the starting materials for synthesis of your new drug are made under nonGMP conditions?

  • You have 0.2% of an unidentified impurity in your GMP drug substance, and would like to know if you need to identify this impurity prior to filing an IND?

  • Your solid oral dosage form is made with a thus far non-approved excipient, and you would like to know what specific studies need to be undertaken with this excipient prior to filing and IND?

  • Your new drug is administered using a new delivery device for intranasal delivery. You would like to know if the Regulatory Agency has any CMC requirements specific to this drug-delivery system beyond those outlined in the applicable regulatory guidances?

  • Etc...

With so many possible questions to ask a Regulatory Agency, CMC-Rx Consultancy can help you determine which CMC aspects of your project warrant a discussion with the Regulatory Agency as part of a Pre-IND meeting. We'll review your CMC documentation, have discussions with your drug development team, and formulate the questions to submit to the regulatory agencies. We'll also prepare the briefing documents for the meetings with the Regulatory Agency.


review of ind submission

Ready to file an IND but would like an external consultancy agency to review your IND submission? CMC-Rx Consultancy reviews CMC-sections, Chapters 3.2.S and 3.2.P.


authoring of CMC-sections of ind and nda

With a strong background in chemistry, CMC-Rx Consultancy also authors comprehensive CMC-sections (Chapters 3.2.S and 3.2.P) for IND and NDA filings.