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Regulatory "Events"

Most startups consider their regulatory submissions as a singular “Event”.

One that takes place when approaching the regulatory authority to start a clinical trial, consult, or obtain designation/approval.


Regulatory experts are irreplaceable, as crafting a smart submission that is aligned with the company’s strategy and goals requires experience and intelligence.

The best is to have them on board, but in early phase, it's a luxury many companies can't afford.


So when the time comes (and money), they would hire a regulatory consultant or an agency, throw in all their documents and data, and let the magic happen on the other side of the screen.


Aside from the fact that this usually takes longer than expected, and costs more than estimated, there are some lost benefits when the process is outsourced to someone else.


The process of writing a regulatory submission:

  • Sharpens the data interpretation and deepens your knowledge

  • Helps identify gaps and risks in the project

  • Establishes the narrative behind the control strategy (and oftentimes sends you back to the previous bullet point in doing so)

  • Articulates the company’s message to the regulator, which will then be the substance of the discussions and IRs that will follow.

So how to make the best of this “event” and reduce the time it takes and cost when you don’t have an in-house regulatory team?

  • Get the development team familiar with the regulatory process your company is pursuing

  • Collect source documents for submission in a designated folder structure that prevents ambiguity and/or mark the documents with appropriate metadata to keep things clear as submission material

  • Have the team draft the backbones of the CTD chapters as data becomes available and not when due for submission (remember: deleting and polishing is much faster than writing and recalling)

  • If an IND/IMPD is already on file, make a working copy for the next version and add placeholders for items to update in the next submission in real-time (+repeat previous bullet)

  • Train your own proprietary GPT engine with project documents for quick data retrieval and drafting (don’t forget to consult with your legal and IT first!)

  • (Embarrassing to write this in 2023, but:) Make sure that data is possible to extract from the reports (e.g. scanned pages). Otherwise- get hold of the original data files NOW, and keep a QA-approved locked copy. Don't rely on OCR (Optical character recognition) as it oftentimes makes mistakes

And most important of all- start now!

These things take time, are inexpensive, and ALWAYS end up on the critical path.



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Don’t know where to start?

Waiting for a funding round, and wish to improve your portfolio in the meantime, without expensive outsourcing?


Join our next Hands-on workshop on writing your IND/IMPD Quality sections (Module 3 of the CTD).

Designated tracks according to the development stage.

Intended for Startups and Development teams, and for junior teams in Regulatory Affairs.

Don't wait for the critical path! Start now: Workshop.BeyondCMC.com

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