Medipha UK

Regulatory affairs

Medicines and medical devices

Lire plus

Business Development

Vous recherchez un dossier, une AMM…

Lire plus

Pharmacovigilance

Vos préoccupations de pharmacovigilance prises en main par nos experts !

Lire plus

AMM

Exploitation, Hébergement et Maintenance

Lire plus

Matière première

Sourcing, dédouanement et livraison

Lire plus

Lancement et Exploitation

Market access et distribution

Lire plus

eCTD Management

Cycle de vie de votre AMM

Lire plus

Réseau Européen

La réglementation en temps réel !

Lire plus

Medipha Santé

Medipha Santé is for nearly 15 years now, a French pharmaceutical company with the status of « exploitant » and importer (batch certification and storage of model samples), offering other national or international pharmaceutical laboratories a wide range of services in the health field (medicines for human and veterinary use, medical devices). Thanks to its experience and thanks to its status and organisation, Medipha Santé provides its clients with expertise and assistance quickly and in complete confidentiality.

Specialist in French regulatory affairs

The benchmark for 15 years !

News and events

Brexit

On 29 March 2019, the United Kingdom will leave the European Union. Unless the current negotiations set another date or provide for a transitional period, the EU-regulations will no longer apply to the United Kingdom, which will be considered a third country to the European Union as from 30 March

ANSM – MA – Translations

A new process has been established by the ANSM regarding the translations submitted at the end of mutual recognition or decentralised procedures (national phase). The declaration of conformity of the translations is now applicable to initial MA applications and renewals.