Life sciences eDiscovery for MHRA, EMA and FDA work.

Life sciences and pharmaceutical work sits under some of the most exacting regulatory oversight of any UK sector. The Medicines and Healthcare products Regulatory Agency, the European Medicines Agency, the US Food and Drug Administration, and the various national competent authorities all reserve the right to inspect, request records and, where warranted, prosecute. When any of those requests arrive, the data landscape they land on is highly regulated, highly distributed and highly sensitive.

We support life sciences general counsel, quality and compliance leaders, and their external advisers on the eDiscovery obligations that follow. Our work covers regulator inquiries under Good Manufacturing Practice and the wider GxP frameworks, product liability claims involving marketed medicines and devices, clinical trial disputes, off-label marketing investigations, transfer pricing and pricing-related regulatory work, and the cross-border disclosure that follows an FDA or EMA information request.

The data is the difficulty. Clinical trial records live in electronic data capture systems, electronic trial master files, laboratory information management systems and validated document management platforms. Manufacturing records sit in batch record systems, deviation and CAPA logs, and the associated email and chat trails. Pharmacovigilance data is held in dedicated safety databases with their own audit models. Preserving and collecting from these systems without disturbing the underlying validation state is a specialist exercise, and one we scope directly with the sponsor's quality function before any capture takes place.

Review is configured for the specific inquiry. Personal health data is identified and handled under the UK GDPR and the Data Protection Act 2018, with special-category safeguards applied at ingestion rather than at production. Where the matter touches multiple jurisdictions we design a review population that meets both UK and EU standards, and we handle US disclosure alongside without a second collection.

Cross-border transfers are managed under the current UK international data transfer instruments and the EU Standard Contractual Clauses, with transfer risk assessments recorded on the matter file. Where the sponsor prefers on-premises hosting we host in a UK data centre; where cloud is acceptable we use UK-region RelativityOne, and either way the residency choice is documented in the matter opening memorandum.

Production is delivered in the formats the receiving regulator or opposing party actually works to, with an audit trail that traces every produced document back to its collection, processing and review record. The evidential path is unbroken.