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

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Digital Health Regulatory Compliance and Enforcement Testimonial

We have advised a start-up on the regulatory qualification and classification of its health application under the MDR, including the determination of whether the software qualifies as a medical device or as a wellness product.

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.

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.

Healthcare Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have advised pharmacies on the regulatory aspects of pharmaceutical compounding.