Precision Counsel for the Life Science Frontier

Covering the entire product lifecycle from R&D through to commercialization. Specialized legal teams offer guidance on regulatory compliance, intellectual property (IP), corporate transactions, commercial operations, patent prosecution, global licensing frameworks, whilst they work hand in hand with compliance and risk management experts to the extent needed.

Intellectual Property (IP): managing, protecting, and defending patent portfolios and proprietary technology from R&D to market. Regulatory Compliance: navigating FDA/EMA and other authorities, clinical trial agreements, and data privacy regulations. Corporate Transactions & Funding: structuring licensing deals, joint ventures and conducting due diligence. Corporate Governance: assisting with incorporation, founder equity, corporate governance matters. Commercialization & Market Access: developing legal frameworks for product launches, supplier, manufacturing and distribution agreements, and navigating market access and pricing issues.

510(k) and PMA submissions, design patent strategy, connected device data privacy, and cross-border M&A advisory.

Legal services for diagnostics businesses, including radiology, teleradiology, pathology, IVD, and all medical modalities with focus on navigating complex regulatory environments, ensuring data privacy, and managing operational risks. Corporate and Commercial Contracts: structuring joint ventures, M&A transactions, supplier/vendor agreements, service agreements. Regulatory Compliance & Licensing: adherence to FDA, IVDR/MDR and local regulations regarding laboratory-developed tests (LDTs), CE marking and Independent Diagnostic Testing Facility (IDTF) standards. Data Privacy and Security: compliance with HIPAA, GDPR, and other international laws protecting patient data, particularly regarding cross-border data transfer in teleradiology and AI diagnostics. Liability and Risk Management: handling malpractice, negligence claims, product liability, specifically for remote diagnostics, AI-assisted decision making, and professional liability for clinicians. Healthcare Fraud & Abuse: counseling on compliance with Anti-Kickback Statutes, Operational matters, Companion Diagnostic partnerships.

Full-scope of legal, compliance, risk management services for NHS Trusts, private healthcare clinics, care homes, longevity and other private boutique healthcare and lifestyle settings, including digital health compliance, telehealth regulatory frameworks, HIPAA/GDPR architecture, and health system joint ventures.

Expert medicolegal advisory spanning clinical negligence, product liability, informed consent, and regulatory investigations across healthcare and life sciences. Medical malpractice defense and claimant representation, expert witness coordination and medical evidence review, coroner's inquests and fatal accident inquiries, professional regulatory proceedings before the GMC, NMC, and GPhC, healthcare fraud investigations, patient safety incidents and duty of candour compliance, and cross-border medicolegal disputes involving multi-jurisdictional regulatory frameworks.