Pharma & biotech diligence · US & EU
Don't buy a delay.
Diligence stops at the science. The risk doesn't. We assess clinical, regulatory, manufacturing and supply risk as one, for FDA and EMA markets.
The offer
Delay Risk Review
One joint review of a pharma or biotech deal, before the investment committee.
What you get
- 01
A clear signal
Proceed, proceed with conditions, or walk away.
- 02
Better terms
Evidence to adjust price, milestones and warranties.
- 03
Deal protections
Conditions to build into the agreement.
- 04
AI readiness
The target's AI tested for real value and regulatory scrutiny, not just the demo.
- 05
A 100-day plan
The risks to fix first after closing.
Why it matters
The data says the risk sits after the science.
>50%
of published FDA rejection letters cite manufacturing or facility issues. Only 27% ask for more clinical data.1
~1 in 5
EU marketing authorisation procedures at the EMA ended in withdrawal (1995–2025).2
62%
of US drug shortages were caused by quality problems. In the EU, over half stem from manufacturing.3
~$500k
in sales lost for every day a drug reaches the market late.4
- 1 Jefferies analysis of published FDA complete response letters (BioSpace, May 2026).
- 2 Analysis of EMA authorisations, withdrawals and refusals 1995–2025 (Naunyn-Schmiedeberg's Arch Pharmacol, 2026).
- 3 US FDA, 2013–2017 shortages (Congressional testimony, Oct 2019); European Parliament.
- 4 Tufts CSDD (2024).
Good deals, protected. Good medicines, delivered.
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