Developing the CMC Package for Veterinary Pharmaceutical Products

Before you can begin clinical trials with your product you need a formulation, manufacturing process and control methods to meet the regulatory standards. 

When developing your product and selecting suppliers of raw materials and packaging materials it can be challenging to maintain compliance for Chemistry, Manufacturing and Controls (CMC) data packages. Regulatory standards are evolving so you’ll need to ensure that the CMC data you generate are aligned with the latest guidance.

Training to help you navigate the regulatory pathway to successful CMC development will give you the confidence that your veterinary medicine CMC dossier is compliant and ready for submission in the EU.

Things to consider when developing the CMC package:

  • Understand the current EU regulatory framework
  • Impact of scale-up and process validation on the regulatory timeline
  • Clinical and regulatory batches are representative of the proposed commercial product
  • Control methods have been validated as required by VICH
  • Stability studies will support a practical shelf life and storage conditions
  • Prepare the Part II or CTD Module 3 to meet current standards and support post approval change

Knoell and Management Forum have teamed up to deliver training on managing your CMC dossier, and the first course is running on 18 March 2024.



Published on Feb 20, 2024 by Gareth Cartman