Pharmacovigilance & Drug Safety

A compliant, audit-ready pharmacovigilance system across the EU, UK, and US — from PV system design and QPPV support through individual case and aggregate reporting, signal management, and health-authority inspections.

EU GVP modules · UK MHRA & UK QPPV · US FDA 21 CFR 314.80 · EudraVigilance & ICSRs · PSURs / PBRERs · Signal management · PV inspection readiness

What we do

A marketing authorisation is the beginning of a safety obligation, not the end of it. Holders of approved products carry a continuing, non-delegable duty to detect, assess, understand, and report the safety profile of their medicines — and to do so completely, accurately, and on time in every market where the product is sold. We help biotechnology and pharmaceutical organisations build and run pharmacovigilance systems that meet EU, UK, and US requirements, and that hold up under inspection.

Whether you are launching a first product, expanding into a new region, or strengthening an established safety function, we provide practical, proportionate support across the full PV lifecycle — surveillance, case management, aggregate reporting, risk management, signal detection, and audit and inspection readiness.

European Union

Compliance with the EU Good Pharmacovigilance Practices (GVP) and Regulation (EC) No 726/2004 and Directive 2001/83/EC.

• PV system & PSMF — design and maintenance of the pharmacovigilance system and the Pharmacovigilance System Master File (GVP Module II).
• QPPV — EU Qualified Person Responsible for Pharmacovigilance support, deputies, and back-up arrangements.
• ICSR management — case intake, assessment, MedDRA coding, and electronic reporting to EudraVigilance (GVP Module VI; E2B(R3)).
• Aggregate reporting — Periodic Safety Update Reports (PSURs / PBRERs) and PSUR single assessment (PSUSA) (GVP Module VII).
• Signal management — detection, validation, prioritisation, assessment, and EMA/PRAC interactions (GVP Module IX).
• Risk management — Risk Management Plans (RMPs) and additional risk-minimisation measures (GVP Module V).
• Literature monitoring, audits & CAPA — surveillance of the scientific literature, PV system audits, and corrective and preventive action (GVP Modules IV and others).

United Kingdom

Post-Brexit UK pharmacovigilance under the Human Medicines Regulations 2012 and MHRA guidance, aligned to but distinct from the EU regime.

• UK QPPV — provision of a UK Qualified Person Responsible for Pharmacovigilance, as required for UK marketing authorisations.
• MHRA reporting — ICSR and aggregate submission via the MHRA Gateway / ICSR Submissions portal, and management of UK-specific timelines.
• UK PSMF annex & RMPs — UK pharmacovigilance system documentation and UK risk-management commitments.
• Great Britain / Northern Ireland — navigation of GB and NI requirements under the Windsor Framework, including divergence from EU procedures.
• Signal & PSUR obligations — UK signal management and periodic reporting where these run separately from the EU.

United States

US postmarketing safety reporting for approved drug and biologic products under 21 CFR 314.80, 314.81, and 600.80, and inspection readiness under FDA's Postmarketing Adverse Drug Experience (PADE) compliance programme.

• Written procedures — surveillance, receipt, evaluation, and reporting SOPs that satisfy 21 CFR 314.80(b).
• Expedited & periodic reporting — 15-day Alert reports, PADERs / PBRERs, and NDA annual reports, submitted electronically via the FDA ESG / Safety Reporting Portal.
• ICSR & literature handling — case processing, follow-up, and scientific-literature reporting to FAERS.
• Contractor oversight — vendor governance and Safety Data Exchange Agreements, with the clock-start and accountability rules FDA expects.
• PADE inspection readiness — mock inspections, document-request and sample-pull preparation, and mock Form FDA 483 response strategy aligned to FDA Compliance Program 7353.001.

Who we help

Emerging biotech preparing for first approval and launch; established pharmaceutical companies expanding into new regions; and organisations strengthening, remediating, or outsourcing an existing PV function. We scale support from interim QPPV cover and a single periodic report through to building a complete, multi-region safety system.

Practical, proportionate, inspection-ready

We combine hands-on regulatory experience with a compliance-first mindset, so your pharmacovigilance system is not only compliant on paper but defensible in front of an EMA, MHRA, or FDA inspector. Every recommendation is mapped to the controlling regulation and sized to your stage and resources.