Medipha Santé: the expert in pharmaceutical operations and regulatory affairs

Medipha Santé: the expert in pharmaceutical operations and regulatory affairs

Medipha Santé: the expert in pharmaceutical operations and regulatory affairs

Working since 2004 as an operating and certifying laboratory for the pharmaceutical industry, Medipha Santé has a portfolio of complementary services, which it undertakes to provide to European and international manufacturing partners.

Medipha Santé or the facilitator of access to medicines

For almost 20 years, Medipha Santé has been supporting the pharmaceutical industry, its customers, but also French hospitals and their patients. Thanks to its status as an operator and importer, this French company has been able to develop a large network of partnerships with national and international pharmaceutical companies. This has resulted in a hundred or so clients worldwide and nearly 350 dossiers submitted each year to the French Agency for the Safety of Medicines and Health Products (ANSM), as well as a multitude of other European procedures.

This status allows Medipha Santé to build a wide range of services in the health field, but also to be of significant assistance to its clients. Its competences include pharmacovigilance, regulatory affairs, quality assurance and the marketing of drugs in the city and in hospitals. With this growing experience and legitimacy, Medipha Santé facilitates the market access of innovative medicines for public health. The marketing of essential anesthetics for the treatment of intensive care patients is a good example of the company’s role as a facilitator of access to care for patients and support for professionals. This support is all the more crucial in these times of health crisis and shortage of essential medicines.

Enriched expertise for complete support

The services designed and deployed by Medipha Santé enable it to handle all the regulatory operations inherent in the distribution of medicines in France. The company thus acts as a privileged interlocutor of the health authorities. Very aware of the challenges and needs of a changing market, Medipha Santé ensures continuity of supply, thanks to the close links it has established with its suppliers, but also with its customers by anticipating their needs. More concretely, Medipha Santé’s services are illustrated in several key areas:

  • Regulatory affairs: the response to the registration needs of drugs or active substances. Medipha Santé handles the application for marketing authorisation (MA), its proper follow-up, price/reimbursement applications, eCTD or assistance with medical device files or the translation of files.
  • Pharmacovigilance: handling the pharmacovigilance aspect requires a high level of scientific, pharmaceutical and medical expertise, both nationally and internationally. National coverage by a person in charge of pharmacovigilance, who is responsible, among other things, for monitoring the local scientific and medical literature, but also at European level, via a person qualified in the relationship with the European Medicines Agency (EMA).
  • Launch and “exploitation”: whether on its own behalf or on behalf of its client, Medipha Santé manages this phase of the process in France as well as in several European markets. From the preliminary market study to the delivery of the products to hospitals or pharmacies, the company has integrated expertise in all distribution channels (tenders, wholesalers, pharmacies).
  • European network: For 10 years, Medipha Santé has been part of a hive of consultants (EUDRACON) specialized in regulatory affairs and pharmacovigilance.


A commitment to confidentiality and quality

Medipha Santé is part of a demanding environment where confidentiality and personalised support are paramount. This operating laboratory gives French patients access to new, innovative medicines that meet the current challenges facing society, but also to the latest innovations in the pharmaceutical sector. With this in mind, Medipha Santé has signed an exclusive partnership with the company VeggiePharm. The latter markets 100% vegan medicines and food supplements that are aimed at both vegan patients and patients who are concerned about the animal cause. The company also accompanies new generation experimental treatments on the French market.

Medipha Santé is a human-sized company with a proven track record. Pursuing its development while preserving the respect of ethical values, flexibility and quality of service is also one of Medipha Santé’s priorities. With the main objective of defending the interest of the French patient, the company tends to become the partner of choice for plural and qualitative pharmaceutical projects.


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