Who we are

I have been a lawyer for 40 years advising clients in relation to the regulation of medicinal products and medical devices in the EU. In this time there really is nothing that I have not seen before.

My areas of expertise include:

• Advising clients on the complete life cycle of medicinal products from, scientific advice, clinical trials, interactions with competent authorities, applications for marketing authorization, packaging and labelling

• Advising clients on the complete life cycle of medical devices from classification, through clinical investigation, interactions with competent authorities and notified bodies, conformity assessment, packaging and labelling. Particular experience in diagnostic and companion diagnostic devices

• Preparation of Compliance Policies and related SOPs and related training activities

• Promotion and marketing activities including participation in MRCs and PRCs

• Interactions with healthcare professionals including consultation agreements, promotion and marketing activities, and investigator-initiated studies

• Preparation of quality agreements, critical supply agreements, manufacturing agreements, distribution agreements, clinical trial agreements, and CRO agreements

• Support of clients in audits by competent authorities and notified bodies, including response to audit findings and related discussion with competent authorities and notified bodies

• Regulatory due diligence in transactions and support in preparation of relevant provisions of sales agreements, APAs, and transition services agreements

• Litigation before the European Courts of Justice and the EFTA Court

  I work regularly with legal, clinical and technical experts including the Genotype Network. The details of some of our external experts are provided in following pages in the Site.