Contact-us: + 33 1 69 59 23 00 HOME COMPANY “EXPLOITANT” SERVICES ... CONTACT UK Contact us Contact us: +33 1 69 59 23 00 GPS address 19, Avenue de Norvège 91140 Villebon-sur Yvette. Postal address Les Fjords – Immeuble Oslo 19 avenue de Norvège 91953 COURTABOEUF Cedex I accept that by sending this email, the personal data collected (name, surname, email address) will be processed in compliance with the GDPR and will be used only to receive our newsletters and answer your questions. 7 + 2 = Send Our network A few links Medipha Santé © 2018-2021 · Legales notices Ce site n\'utilise pas de cookies. This website doesn\'t use cookies. French regulatory affairs specialist Médipha Santé : all the skills of an « exploitant » !

Contact-us: + 33 1 69 59 23 00 HOME COMPANY “EXPLOITANT” SERVICES ... European network: Regulations in real time Médipha Santé is member of an European consultants network (EUDRACON) specialized in regulatory affairs Photo des membres EuDRAcon à Paris en avril 2014 More than 10 years ago Medipha Santé has joined the network EuDRAcon (abbreviation for European Drug Regulatory Affairs Consultants), a pan-European network of regulatory affairs consultancy companies, dealing with medicines, medical devices, cosmetics and food supplements. Founded in 2007, EuDRAcon conducts business in a network of nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. The local presence of service providers, such as Medipha Santé for the French market, ensures the reliable management of national steps. Before joining the EuDRAcon network, each prospective company undergoes extensive background checks, as EuDRAcon’s goal is to further increase the networks strength with partners who have the same vision and policy – to be accountable, flexible and reliable. As an EuDRAcon member, we can offer you quality, flexibility and cost-effectiveness across different markets. Our network A few links Medipha Santé © 2018-2021 · Legales notices Ce site n\'utilise pas de cookies. This website doesn\'t use cookies. French regulatory affairs specialist Médipha Santé : all the skills of an « exploitant » !

Contact us: + 33 1 69 59 23 00 HOME SOCIETY OPERATION SERVICES ... AMM: Operation, Hosting and Maintenance Medipha Santé supports you by: Strategy Compliance with requirements for each type of variation Preparation of supporting documents Submission of variations following the appropriate procedure Renewals Pharmacovigilance (Medipha Santé can act as "local QPPV") Management of the sunset clause Literature watch Regulatory watch Implementation of Safety Data Exchange Agreement (SDEA) Maintaining the local PSMF Maintenance of opening authorizations, BPD certificate In accordance with article L.5121-1-3 of the Public Health Code, please click here to search for the list of active ingredients of drugs of which Medipha Santé is the holder and / or operator. Our network Some links Medipha Santé © 2018-2021 · Legal notices This site does not use cookies. This website doesn \ 't use cookies. French regulatory affairs specialist Médipha Santé: all the skills of an "operator"!