We have advised an importers, distributors on a complex international supply chain strategy under the MDR.
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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 pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.
We have negotiated clinical trial agreements on behalf of several sponsors.
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 advised several clients on legacy status and the impact of the targeted revision of the MDR and IVDR.
Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.