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:
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Future regulatory submissions (IND/IMPD)- including updates of existing files
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Gap assessment of your CMC Development plan for 2024
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Communication with potential investors, service providers (especially CDMOs), consultants, new team members and more
Ideal for:
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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
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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...