Updates

We have advised pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.

We have assisted a large company in setting up a patient support program.

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

We have assisted a pharmaceutical company with the alignment of its promotional materials with applicable codes of conduct.

We have worked with a multinational medical device company to ensure compliance of its advertising materials with local advertising and promotion rules in the Netherlands.

We have advised a client on collaborations between pharmaceutical companies and healthcare providers and contract research organisations, including the negotiation of framework agreements for clinical research.

We have advised several clients on the classification of their medical devices, including software products, under the MDR and IVDR, and have helped them in negotiating.

We have advised an importers, distributors on a complex international supply chain strategy under the MDR.

We act as regulatory counsel to authorised representatives of non-EU manufacturers.

We have advised on commercial contracting and borderline classification cases.