Updates

What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

We have advised several clients on the conduct and defence of complaints made to the Dutch Advertising Committee regarding claims about products such as foods, pharmaceuticals and medical devices across Dutch media.

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

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

We have litigated in a pharmaceutical case concerning the validity of marketing authorisations.

We regularly assist clients with pricing and reimbursement procedures in the Netherlands.

We have negotiated clinical trial agreements on behalf of several sponsors.

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.