Chemicals
Medical Devices
Environmental and Sustainability
Regulatory Compliance and Enforcement
Testimonial
We have advised a medical device manufacturer on the regulatory implications of the restriction on synthetic polymer microparticles for its products.
Chemicals
Regulatory Compliance and Enforcement
Spin-out and Starter Advisory
Testimonial
We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.
Chemicals
Regulatory Compliance and Enforcement
Testimonial
Our team advised a client on the registration process under REACH.
Healthcare
Data Protection, (Cyber)security and AI
Testimonial
We have advised a healthcare institution on the conditions under which medical professional secrecy may be breached.
Cosmetics
Regulatory Compliance and Enforcement
Testimonial
We advised a mid-sized company on the qualification of a cosmetic product to facilitate its compliant and effective market launch.
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 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
Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.
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.
