Regulatory compliance advisory for life sciences

Clarity for complex regulation across the EU, UK and US: regulatory strategy, pharmacovigilance, audits and inspections, and product compliance.

Coming soon

Practices

Each practice area is staffed by senior advisers with direct experience of the relevant rules, regulators, and regulatory decisions.

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.

To learn more about our practices, please contact us to arrange a discussion.