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Explore our latest insights, regulatory updates, and strategic reports for the life sciences sector.

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26 results

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Pharmaceuticals Litigation Regulatory Compliance and Enforcement Testimonial

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

Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

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

Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

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.

Pharmaceuticals Commercial Contracts Testimonial

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

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

Diagnostics Regulatory Compliance and Enforcement Testimonial

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.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.