Expertise / Pharma & Life Sciences / Regulatory affairs (MHRA, EMA, FDA)
Regulatory affairs (MHRA, EMA, FDA) expert witnesses
Evidence on regulatory frameworks and approvals across MHRA, EMA and FDA.
Request an expertRegulatory disputes require an understanding of how products are approved and maintained across major frameworks. Our experts navigate MHRA, EMA and FDA requirements and explain them clearly.
In pharma & life sciences, the difference between a strong case and a weak one often comes down to whether the expert truly understands the sector. Generalist opinion rarely survives scrutiny on specialist questions, and a tribunal gives little weight to evidence that misreads how pharma & life sciences actually works. We focus here precisely because the issues are technical, the stakes are high, and the wrong expert is an expensive mistake.
What instructing through us looks like
Tell us the issues, the forum and your timeline. We check fit, availability and conflicts, then send a short, honest shortlist. You review CVs and speak with the expert before instructing — the instruction and fees are agreed directly between you and the expert, on your terms. New to the process? See our guide on how to instruct an expert witness.
FAQ
Common questions
What does a regulatory affairs (mhra, ema, fda) expert witness do?
They give independent, objective opinion to a court or tribunal on regulatory affairs (mhra, ema, fda) issues within pharma & life sciences, with an overriding duty to the court under CPR Part 35. The opinion usually takes the form of a written report and, where required, oral evidence.
When should I instruct a regulatory affairs (mhra, ema, fda) expert?
As soon as the issues are clear. Early instruction helps you test the strengths and weaknesses of the case, scope the evidence proportionately and avoid a rushed report against a deadline.
How do you select experts for regulatory affairs (mhra, ema, fda) matters?
On substance — relevant qualifications, genuine pharma & life sciences experience and an understanding of an expert's duties in litigation and arbitration. Where an expert has limited experience of giving evidence, we say so.
Need a regulatory affairs (mhra, ema, fda) expert?
Describe the matter and we'll identify specialists who fit.
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