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.
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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 regularly advise start-ups and large scale manufacturers on clinical evaluation and clinical investigation requirements. We have assisted a start-up with have supported a mid-sized medical device company in preparing its clinical evaluation report for a high-risk device.
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.
We have assisted a pharmaceutical company with the alignment of its promotional materials with applicable codes of conduct.