Medis Launches New Regulatory Affairs Service
Medis has launched a new service offering regulatory advice and support to companies seeking to supply pharmaceuticals to the European marketplace.
Commenting on the move, Stuart Colligon, Managing Director, said "Medis specialises in the sales and licensing of pharmaceutical products and intellectual property, in the form of registration dossiers. A key aspect of our work requires securing regulatory approval for generic products, prior to patent expiry. Our success in doing so has given us extensive experience of every aspect of European regulatory policy and practice, and this has prompted us to offer this expertise to clients who are seeking to gain European registrations for pharmaceutical products."
Medis commented that the stakes for any company offering pharmaceutical products to the growing European market have never been higher. Critically, the reduction of time taken to reach market is often vital to a product's success, and the professional handling of regulatory approval plays a key role in the profitability of any newly marketed drug.
Medis will offer a range of options designed to facilitate the authorisation via all of the major procedures for regulatory submission and approval in Europe: National; Decentralised; and Mutual Recognition; and will advise on the most appropriate route in any given circumstance. Medis will also offer assistance with pharmacovigilance functions.
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