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We navigate the complex landscape of pharmaceutical regulations to ensure your innovations reach the market safely and efficiently.
Supporting the development of clients’ cutting-edge treatments through ensuring that regulatory requirements are met in a rapidly changing healthcare landscape.
Ensuring clients’ pharmaceutical products adhere to both legal and regulatory standards.
Providing expert guidance, personalised support, proactive market access strategies for clients’ products.
Our team is committed to providing strategic guidance and robust support, helping you overcome regulatory hurdles and achieve your goals. We advise clients on all aspects of regulatory and compliance requirements, including:’
Our advisers act on domestic and international projects of all shapes and sizes, working with many of the leading names across this diverse sector. Browse our experience below, or use the filters to look-up recent work in particular geographies and legal disciplines.
Representing a client in proceedings brought before the General Court of the EU, seeking annulment of the European Commission’s decision to grant conditional marketing authorisation for an advanced therapy medicinal product.
Advising a global pharmaceutical company on interpreting the new ‘affordability mechanism’ within the UK government's ABPI VPAG.
Advised a global pharmaceutical company on the marketing authorisation application process of orphan drug exclusivity rights for a medicinal product for regulatory data protection (RDP) in the United Kingdom.
Acted for Teva in multiple cases concerning data, market and orphan incentives before national courts, the EU General Court and CJEU.
Advising on two separate products for a global pharmaceutical company and a biotech firm, focusing on the preparation of submissions to the European Medicines Agency to secure orphan drug exclusivity at the final review stage.
Advised Accord in proceedings before the EU General Court concerning its marketing authorisation for a generic dexmedetomidine product, considering the appropriateness of a Reference Medicinal Product.
Advising a listed biotechnology company headquartered in Switzerland on the conduct of pre-clinical and clinical studies in the field of biologically produced radiopharmaceuticals.
Acted for Clinuvel in its successful appeal and subsequent judicial review proceedings in the English High Court against a decision of the UK market access agency, NICE, refusing to commission its product afamelanotide (Scenesse®) for routine use in the NHS.
Our expertise, at your disposal
With over 490 partners and 3000 people around the world, we are well-placed to support you across a full range of legal and advisory services.
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Medicines regulation
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Multinational law firm Pinsent Masons has advised Revera Energy (Revera), a global independent energy platform backed by global investment firm Carlyle, on all construction and optimisation aspects of the 400MW / 800MWh Hunterston BESS Project.
Pinsent Masons has advised Avanton on its partnership with Hyde in relation to 64 social rented homes at THE BeCa, Old Kent Road.
Multinational law firm Pinsent Masons advised Erste Group Bank and Erste Bank Polska on an investment loan granted to Eastnine, a company listed on Nasdaq Stockholm.
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