Securing a Startup’s Regulatory Strategy During a Funding Round Before Investor Discussions

Context

A French startup in the process of structuring its business was developing two cutaneous application products based on an innovative biomaterial with:

• No defined regulatory qualification,
• No in-house regulatory team,
• Investors to convince within tight deadlines.

The challenge

The absence of regulatory visibility directly threatened the project’s viability: incorrect claims, unsuitable tests, submission delays, unexpected costs. Mistakes at this stage could have jeopardised the funding round.

The One Health Compliance solution

• Definition of clear strategic regulatory scenarios, understandable by non-specialists with impact analysis for each option, associated regulatory and quality roadmap, and prioritised decision criteria to move forward quickly.

The result

• Rapid and secure decision-making.
• A decision-support tool directly usable in investor discussions and as part of regulatory due diligence.

✓ Secure decision ✓ Clear regulatory roadmap ✓ Tool ready for investors

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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