Regulatory & CMC Due Diligence

Know what could sink the asset before you sign

For investors, acquirers and licensing teams: an independent, risk-scored review of the regulatory pathway, CMC, manufacturing site and safety record of a medicine or medical device. Every risk comes with its likelihood, its cost in time and what would fix it.

Request a review See an example report

Under NDA from the first call
Fixed scope and fixed price
EU, US and MENA pathways

Weighing the riskrest

Move along the beam to tip the balance

What we check

Four areas where deals lose value after closing

Each area gets a score from 1 to 5 for likelihood and for impact, a time-to-fix estimate and the evidence behind it, so your investment committee can price the risk instead of guessing it.

Three weeks

From data room to decision

A typical review takes three weeks from data room access. Tell us your signing date and we plan backwards from it.

Example report

One page your committee can read in five minutes

The summary scores every area, names the deal-breakers and gives a time and cost range to fix the rest. The full report holds the evidence for each finding.

Due diligence summary · Asset X, oral solid genericExample layout

Regulatory: Medium GCC filings depend on an EU reference dossier still under assessment
CMC: High Process validation covers one of two registered batch sizes
GMP site: Low Last authority inspection closed with minor observations only
Safety: Low No open signals; PSUR cycle and RMP up to date
Verdict: Proceed, with validation of the second batch size as a condition before closing

Request a review

Tell us about the asset and your timeline

We sign your NDA before any detail changes hands and reply with a scope and fixed quote.

IndependentWe have no stake in the asset, the seller or the outcome.
EU and MENA in one reviewEMA and national pathways next to SFDA, GCC and North African authorities.
Priced riskEvery finding comes with a time and cost range, not just a colour.