Regulatory Compliance

Regulatory landscapes shift like sand. A misstep in compliance can mean fines, operational freezes or irreversible reputational damage.

Read case study

Our Approach

We build agile compliance ecosystems that evolve with legislation, blending legal expertise with operational pragmatism.

Key Offerings

Gap analyses identifying compliance vulnerabilities across supply chains, HR practices and financial reporting.

Industry-specific frameworks for highly regulated sectors such as fintech, healthcare and energy.

Workshops to upskill teams on EU GDPR, the UK Modern Slavery Act and other critical regulations.

Rapid-response protocols for breaches, including regulator liaison and remediation plans.

Case Study: Multinational Pharma’s Compliance Overhaul

Challenge

A London-based pharmaceutical leader faced EMA sanctions after repeated clinical trial data discrepancies across 12 EU markets. Legacy systems failed to harmonise reporting under evolving MDR requirements and could not meet timelines introduced by Regulation (EU) 2023/607.

Solution Deployed

Implemented a blockchain-enabled trial master file system with automated EUDAMED synchronisation.

Delivered immersive training to 89 QA staff in six languages using AR-assisted compliance scenarios.

Developed an AI-powered regulatory change tracker for 31 jurisdictions with 98.5% prediction accuracy, ensuring real-time MDR alignment.

Results Achieved

Reduced audit discrepancies by 88.9% within 9 months.

Saved £2.34M annually through streamlined reporting workflows.

Secured first-to-market approval for a novel oncology drug in Germany and France.

By clicking ‘Accept’, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.