We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.
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We have assisted a large company in setting up a patient support program.
We have litigated in a pharmaceutical case concerning the validity of marketing authorisations.
We have negotiated clinical trial agreements on behalf of several sponsors.
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.
We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.
We have assisted a distributor of medical devices on questions pertaining to a cleaning solution regulated under the Biocidal Product Regulation.
We have advised a medical device manufacturer on the regulatory implications of the restriction on synthetic polymer microparticles for its products.
We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.
Our team advised a client on the registration process under REACH.