Disputes and due diligence
Expert witness
Independent technical opinion on manufacturing quality and GMP compliance, written for the judge, tribunal or investor who has to rely on it.
Discuss your programmeOverview
Manufacturing disputes turn on technical detail: what the process required, what the records show and what a competent manufacturer would have done. Lawyers need an expert who can explain that clearly and who will not change position under pressure.
Our duty is to the court or tribunal, not to the party who instructs us. If the evidence does not support your position, we will tell you early, so you can decide how to proceed.
What we do
Expert reports
Opinions on manufacturing practice, quality systems and GMP compliance, prepared to the rules that apply in the forum, for example CPR Part 35 in England and Wales, or the equivalent where you are.
Failure and root-cause analysis
Independent review of batch failures, contamination events, deviations and out-of-specification results, and whether the response met the standard expected.
Contract and quality-agreement disputes
Technical review of what a supply, manufacturing or quality agreement required, and whether each party met it.
Technical due diligence
A clear view of manufacturing and CMC risk for investors, lenders and acquirers, ranked by consequence and by cost to fix.
Joint expert work
Preparing for and attending meetings with opposing experts, and agreeing a statement that records what is and is not in dispute.
Testimony support
Preparation for examination and cross-examination, including how to explain a technical point to a non-specialist.
When teams call us
- A CDMO and sponsor disagree about who was responsible for a lost or failed batch.
- A regulatory action or recall is being challenged and counsel needs a technical view.
- An investor or acquirer wants an independent opinion on manufacturing risk before closing.
- You need a consulting adviser to test a case before deciding whether to instruct a testifying expert.
How it runs
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Conflict check and scope
We confirm independence, understand the questions the expert must answer, and agree the timetable and fee basis.
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Document review
We work through the manufacturing, quality and correspondence records and raise gaps with instructing counsel.
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Opinion and report
We set out our opinion, the facts it rests on and the limits of what we can say.
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Hearing support
We prepare for joint meetings, examination and cross-examination.
Common questions
Tell us what you are facing
A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.