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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.

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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.

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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

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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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