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.
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We act as regulatory counsel to authorised representatives of non-EU manufacturers.
We have advised on commercial contracting and borderline classification cases.
We have provided in-house training for the regulatory and quality teams of several large MedTech companies.
We have advised several clients on legacy status and the impact of the targeted revision of the MDR and IVDR.
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 regularly assist clients with pricing and reimbursement procedures in the Netherlands.
We have litigated in a pharmaceutical case concerning the validity of marketing authorisations.
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.