top of page

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.


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:


bottom of page