Life Sciences Regulatory

Our experience includes advising: 

• A US CRO on the implementation of certain clinical trial-related services following the acquisition of Illingworth Research Group in more than 50 jurisdictions worldwide. In particular, we advised the client on the provision of nursing services in the context of clinical trials to be rendered at trial subjects’ homes and at the direction of the trial’s principal investigator.   
• A global medical device company in relation to its diabetes business across 29 jurisdictions, on whether it is possible to market, sell and ship its products directly to customers in each jurisdiction.  
• A US medical technology company on all aspects of medical device regulation including: (i) on discontinuing a previous version of their medical device in 40 countries; (ii) rolling out a sampling program with HCPs throughout Europe; and (iii) on transparency obligations in the MedTech and national industry codes. 
• A global biopharmaceutical company on cell and gene therapy (CGT) regulation in the EU, including in relation to compliance with the EU Tissue and Cells Directive, ATMP Regulation, and broader regulatory challenges arising from the company’s CGT business.
• A US pharmaceutical company in reviewing their internal compliance policies related to medicinal product promotion and HCP interactions in 31 jurisdictions worldwide. 
• A global pharmaceutical organization on its negotiations for the supply of its COVID-19 vaccine across EU and EEA countries.  
• A large medical products manufacturer on a multi-billion euro patent collaboration in relation to a medical contrast agent. Our cross-border, cross-practice team worked on a wide range of complex commercial, competition, IP and patent issues to secure a landmark agreement for the client.