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Hands-on CMC Workshop

Start 2024 with a working draft of your own CTD Module 3

In this workshop, we will walk through the CMC Development aspects of your project and identify the key elements already there, and the ones to work on in the coming year.

We will work our way through the most important Regulatory document for product development, the CTD (Common Technical Document), and focus on Module 3- which describes all the Product quality and manufacturing aspects, known as CMC.

This draft will serve you for:

  • Future regulatory submissions (IND/IMPD)- including updates of existing files

  • Gap assessment of your CMC Development plan for 2024

  • Communication with potential investors, service providers (especially CDMOs), consultants, new team members and more

Ideal for:

  • Early phase / preclinical startups that can't afford expensive regulatory consultants/agencies to write their Module 3, but want to advance their regulatory portoflio and save time/money later on

  • Regulatory teams that need help training junior staff on CMC in general and Module 3 writing

Start in-house today. 

Outsource later, for final touches... 

Don't wait until the regulatory submission is on the critical path...

Populating your Module 3 since day 1 of the project is a powerful tool for knowledge management and guiding your CMC Development efforts.

Please fill in the request form below and we'll let you know if your project is a good fit for the workshop:

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