Updates

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

We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

Our team negotiated a cooperation agreement between a cosmetics brand owner and a manufacturer on behalf of a mid-sized company.

Our team assisted a mid-sized cosmetics company with the negotiation of a distribution agreement.

We have assisted a distributor of medical devices on questions pertaining to a cleaning solution regulated under the Biocidal Product Regulation.