Understanding the regulatory environment in the UK for a range of non-surgical cosmetic interventions
An overseas client wished to understand the regulatory environment in the UK for a number of its non-surgical cosmetic products. It realised that the determination of the regulatory status of these products was complex and required a consideration of the regulations relating to cosmetics, medical devices and medicinal products to determine the regulatory path towards compliance. Our consultants evaluated the products against the different regulatory frameworks (and other regulations and guidelines that might apply) taking into consideration the component substances in the formulations and their levels, the claims made, the intended uses of the products, and their primary modes of actions. This also took into consideration the new medical device regulation ( MDR ) which would soon be required to be implemented. This led to proposed regulatory pathways with high-level compliance costs for each of the products as they currently stood, and suggestions for potential changes that might present more commercially attractive propositions to the company.
We are a specialist medical device consultancy consisting of industry experts with long and successful track records in commercialising medical device products. We have broad functional and sector experience, and would welcome an opportunity to discuss with you any challenge relating to creating sustainable value from medical technologies.
Munna Choudhury of Alacramed will be attending UK BIOTECH SUMMIT 2019, on
Mark Wickham of Alacramed will be attending Med-Tech Innovation Expo 2019 at
We understand the need for accurate, tailored health economic and budget impact
Alacramed Ltd, St Johns Innovation Centre, Cowley Road, Cambridge,
+44 (0) 1223 421885