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.
Diagnostics
Pharmaceuticals
Regulatory Compliance and Enforcement
Testimonial
We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.
Pharmaceuticals
Commercial Contracts
Testimonial
We have negotiated clinical trial agreements on behalf of several sponsors.
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.
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 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.
Diagnostics
Regulatory Compliance and Enforcement
Testimonial
We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.
Diagnostics
Regulatory Compliance and Enforcement
Testimonial
Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.
