Risk and compliance

Surfacing deal-blocking risks early—and managing them credibly

We look at your asset and deals the way a sophisticated partner or investor will: through the lens of regulatory, clinical, CMC, IP, access, and execution risk. The goal isn’t to replace legal or regulatory advisors, but to make sure the right risks are seen early, framed correctly, and addressed in a way that keeps the deal moving.

Seeing what counterparties will worry about

We review your plans, materials, and processes from a counterparty perspective: trial design, endpoints, CMC robustness, IP/FTO, safety profile, and early access assumptions. This helps anticipate the questions that will arise in diligence and negotiations—and where you may need stronger data, clearer messaging, or specialist input.

Turning risk awareness into deal readiness

Once key risks are mapped, we help you decide what to fix now, what to monitor, and how to communicate around remaining uncertainty. We align BD, clinical, regulatory, and finance on a common risk picture and embed this into your materials, Q&A, and deal scenarios so you come across as prepared and credible, not surprised or defensive.

Key areas of risk & compliance support

• Risk mapping from a partner’s lens – Identifying regulatory, clinical, CMC, IP, access, and execution risks most likely to affect deal appetite or terms.

• Diligence readiness & hygiene – Structuring data rooms, core documents, and Q&A processes to make reviews efficient and minimise red flags.

• Issue framing & prioritisation – Distinguishing between “must-fix” issues, items to mitigate, and areas to monitor, with clear owner and timeline.

• Cross-functional alignment – Ensuring BD, clinical, regulatory, CMC, finance, and legal share the same risk narrative and responses.

• Coordination with specialist advisors – Working alongside your legal, IP, and regulatory experts so strategic and technical messages stay consistent.

“Credibility in deals comes less from having no risks, and more from showing you understand them and have a plan.”

With risk and compliance addressed proactively, you enter discussions with a clear, consistent story about where the uncertainties are, how they’re managed, and what that means for structure and value—making it easier for partners and investors to say yes.