For BioPharma & private equity

Are you a BioPharma or PE company investing in (pre)clinical candidates? Understand what is changing to avoid delays.

Don't buy a delay

Diligence stops at the science. The risk doesn't.

Where clinical trials were for decades the critical path, it has shifted to getting the product manufactured and to patients, safely and on time.

We assess clinical, regulatory, manufacturing and supply risk as one, for FDA and EMA markets, so you see what could stall the asset before you sign.

>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

One team · Three lenses

A senior team that has seen and lived through these challenges, from inside big pharma, the factory floor and the supply chain.

Medical governance and benefit–risk judgement for FDA and EMA.

CMC, CDMO and supply-chain resilience, from API to patient.

Operational diligence, value creation and AI tested for real value.

Book an introduction call with us