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The 7 Stages of Compliance

The seven stages of regulatory compliance, in a Biotech Startup:


  1. Denial- “we only need to think about it when we’ve secured funding for the next stage” or “we’ll figure it out when we get there”

  2. Panic- when a potential investor (or regulator, God forbid) asks “Did you think about X?” and you’re suddenly not sure if you did

  3. Anger- when you realize the experts you hired didn’t tell you about X either (or you're angry at yourself for not listening)

  4. Acceptance- when you understand that X needs to be done, and you start planning/budgeting for it

  5. Execution- when you finally do X

  6. Evaluation- when you check whether the results are satisfactory and would allow you to move on (probably with a different expert, as you are still not over stage 3)

  7. Submission- when you communicate to the regulator what you did, and hope for approval of the next step


In complex development projects, it is useful to have a map in hand at all times- showing you the way and clearly highlighting what’s missing.


For pharmaceutical products’ quality and CMC development, this map is outlined in Module 3 of the CTD, and it is a critical part of all regulatory submissions worldwide.


Having a Module 3 in hand, even at early stages of development - is extremely useful.


It is a living document that evolves along with the project, and with the additional regulatory requirements that come along with each stage.

I always advise my clients to have a working draft of Module 3 - even before needed for submission. Even as a skeleton.


The development team can populate it without external help and when the time comes to submit, the expensive regulatory experts will be able to polish it much quicker and cheaper.

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If you wish to start 2024 with your own working copy of Module 3 - join our boutique workshop, where you will be guided step by step to make you own working copy of Module 3, and by doing that- understand what needs to be done in your CMC development project.


You don’t need to be a regulatory expert.

You don’t need to kill your budget.


And most important of all- you’ll jump straight to stage 4 and save a lot of time and effort, when the investors and regulators come knocking on your door.


More details here: workshop.BeyondCMC.com

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