Experience that puts policy on your side
The life sciences regulatory landscape is changing fast. The need to respond quickly to a global health crisis prompted an acceleration of research and regulatory processes that is here to stay. With the help of a partner who can cut through ambiguity and uncertainty, this shift can help fuel growth and opportunity for your business.
Awards and recognition
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.
At the Intersection of Science and Law
News and insights
CMS issues first HCPCS code and Medicare DME benefit category determination for...
31 March 2023 .7 minute read
Centers for Medicare and Medicaid Services issues initial guidance on the implementation...
20 March 2023 .6 minute read