The seven stages of regulatory compliance, in a Biotech Startup:
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”
Panic- when a potential investor (or regulator, God forbid) asks “Did you think about X?” and you’re suddenly not sure if you did
Anger- when you realize the experts you hired didn’t tell you about X either (or you're angry at yourself for not listening)
Acceptance- when you understand that X needs to be done, and you start planning/budgeting for it
Execution- when you finally do X
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)
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