Expertise / Pharma & Life Sciences
Pharma & Life Sciences expert witnesses
Rigorous scientific and regulatory expertise for pharmaceutical and life-sciences matters.
Request a pharma & life sciences expertSterile manufacturing in a cleanroom
Few sectors carry more technical and regulatory weight. We work with experts whose backgrounds span clinical research, manufacturing, pharmacovigilance and regulatory affairs, able to give evidence that withstands close scrutiny.
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. New to the process? See our guide on how to instruct an expert witness.
Featured experts
Specialists we work with in pharma & life sciences
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Tell us about your pharma & life sciences matter
Describe the issues and the forum. We check fit, availability and conflicts, then come back with a short shortlist. Enquiries are confidential and create no obligation.
- Tell us the matterShare the issues, the sector and your timeline. No obligation, treated in confidence.
- We shortlistWe identify experts whose experience genuinely fits, and check availability and conflicts.
- You instructYou review CVs and speak directly with the expert before instructing on your terms.
What these disputes actually turn on
Pharmaceutical and life sciences disputes come back to a small number of questions. Was the product made and released as its licence and good manufacturing practice required? Did the company act reasonably on the safety signals it had? Is the product defective, in the sense of being less safe than people are entitled to expect? In a patent case, what did the skilled person know at the priority date? Each question needs a different kind of expert, and the commonest mistake is asking a clinician to answer a manufacturing question, or a formulation scientist to answer a regulatory one.
Manufacturing and supply claims, including contamination, sterility failures, unlicensed specials and shortages that follow a regulatory restriction, turn on what GMP and MHRA guidance required at the time, what the site's own quality system recorded, and whether decisions about capacity and continuity of supply were reasonable on what was known.
What the expert will examine
- Batch manufacturing and release records — including Qualified Person certification.
- Environmental and microbiological monitoring data — with the deviations, CAPAs and out-of-specification investigations that followed.
- Regulatory records — MHRA inspection reports, GMP certificates and correspondence about any regulatory action.
- Quality and technical agreements — between manufacturer, supplier and customer, which allocate responsibility.
- Pharmacovigilance data — individual case reports, periodic safety reports and signal assessments.
- Product information — the SmPC, labelling and its change history; for patents, the prior art and development records.
Paper batch records are kept for defined periods under GMP, but electronic audit trails and raw monitoring data are often harder to recover after a system migration. Ask for audit trails early, before systems change.
What the report has to address
The framework depends on the claim. Manufacturing questions are measured against UK and EU GMP (EudraLex Volume 4, including Annex 1 for sterile products), the Human Medicines Regulations 2012 and the MHRA's guidance on unlicensed medicines. Product liability engages the Consumer Protection Act 1987. Patent disputes are decided under the Patents Act 1977. Where a clinical question arises, the court applies the established standards of care, including the duty on informed consent set out by the Supreme Court in Montgomery v Lanarkshire Health Board.
The standard must be the one that applied at the time. Annex 1 was substantially revised in 2022, with most changes in force from August 2023, and UK and EU requirements have begun to diverge. An opinion that applies today's expectations to events several years ago will not survive cross-examination.
The disciplines, and when each is needed
- GMP, quality assurance and Qualified Person experts — manufacturing, release decisions and quality systems.
- Aseptic processing and sterility assurance — cleanrooms, environmental monitoring and contamination control.
- Pharmaceutical scientists — formulation, stability, impurities and root cause.
- Pharmacovigilance and drug safety physicians — signal detection and the reasonableness of safety decisions.
- Regulatory affairs experts — licensing and compliance with MHRA, EMA and FDA requirements.
- Pharmacists and clinical pharmacologists — dispensing, prescribing and the effect of a medicine on a patient.
- Supply chain and operations experts — capacity planning, continuity of supply and contingency arrangements.
Five questions worth asking before you instruct
- Have they worked in the regulated function at issue, such as QA, QP, production or pharmacovigilance, rather than only studied it?
- Do they know the regime as it stood on the relevant dates?
- If they are a former inspector, were they involved with the site or the regulatory action in dispute?
- Can they read the raw data themselves, such as monitoring trends and laboratory results?
- Which manufacturers, contract organisations and NHS bodies have they worked for? Conflicts in this sector are common.
Why pharmaceutical evidence gets discounted
The commonest failure is arguing from the outcome: contamination occurred, so GMP must have been breached. A tribunal needs the cause traced through the records. The second is applying a later standard to earlier events. The third is an expert straying outside their discipline, which in this sector is easy to do and easy for the other side to expose.
Key authorities and further reading
- The Human Medicines Regulations 2012 — the core UK legislation on medicines
- MHRA: the supply of unlicensed medicinal products (specials) — guidance for specials manufacturers and suppliers
- EudraLex Volume 4: EU GMP guidelines — GMP, including Annex 1 on sterile products
- MHRA: good manufacturing and distribution practice — UK GMP and GDP requirements and inspections
- Consumer Protection Act 1987 — strict liability for defective products
- Patents Act 1977 — the basis of UK patent disputes
- Montgomery v Lanarkshire Health Board [2015] UKSC 11 — the Supreme Court on informed consent
- CPR Part 35: Experts and Assessors — the expert's overriding duty to the court
- Kennedy v Cordia (Services) LLP [2016] UKSC 6 — the Supreme Court on when expert evidence is admissible
FAQ
Common questions
What does a Pharma & Life Sciences expert witness do?
A Pharma & Life Sciences expert witness gives independent, objective opinion to a court or tribunal on specialist issues within pharma & life sciences. The overriding duty is to the court, not to the instructing party. That opinion typically takes the form of a written report and, where required, oral evidence.
When should I instruct a Pharma & Life Sciences expert?
As early as the issues become clear. Instructing early helps you weigh the strengths and weaknesses of a case, scope the evidence proportionately, and avoid a rushed report against a looming deadline.
How do you choose your Pharma & Life Sciences experts?
We select 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.
Do your experts cover clinical trials and pharmacovigilance?
Yes. We work with experts whose backgrounds span clinical trial design and conduct, drug safety and pharmacovigilance, and regulatory affairs across the major frameworks.
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