Practices

Where we advise

Each practice area is handled by advisers with direct, working knowledge of the relevant regulations, authorities, and operational realities.

Filter by sector14 practices

GDPR, privacy by design, and cyber security governance for personal, health, and AI data.

Outsourced and fractional DPO services under the UK and EU GDPR, with a specialism in clinical trials.

Independent audits, mock inspections, gap assessments, and CAPA support across the EU, UK, and US.

Audit-ready pharmacovigilance across the EU, UK, and US, from PV system design to QPPV and inspections.

GCP compliance and inspection readiness across the trial lifecycle, aligned to ICH E6(R3) and E8(R1).

Authorisation strategy, variations, and market access across the full product lifecycle.

Quality management systems and manufacturing compliance, including data integrity and GxP.

EU AI Act readiness, risk classification, and governance for AI in medical and health contexts.

Regulatory risk assessment for M&A and private equity across the EU, UK, and US.

Regulatory support under EU MDR and IVDR, including combination products and digital health.

Food law, cosmetics, novel foods, and chemicals and environmental compliance.

Independent audits and certification readiness against ISO management system standards.

Product safety, recall planning, post-market risk, and engagement with regulators.

Enterprise and quality risk management, business continuity, and crisis response.