Regulatory Affairs

Regulatory Affairs
Product Description

Within regulatory affairs, MEDIPHA SANTE offers a wide range of services which include :Application for marketing authorization, 
Compliance with requirements for every type of MA variation
Monitoring of marketing authorizations, 
Legibility tests, 
Translation services,
Preparation of supporting documents
Submission of variations according to the appropriate procedure
Renewals
Management of the MA sunset clause
Literature watch
Regulatory monitoring
Contact us for more information.

MEDIPHA SANTE

  • Country/Region:
    France
  • On CPHI since:
    2015
  • Employees:
    25 - 49
Company types
Consultancy
Distributor/Import Export
Licensee
Pharmaceutical company
Specifications
  • Selling Points
    Product Features; Quality Service

MEDIPHA SANTE

  • Country/Region:
    France
  • On CPHI since:
    2015
  • Employees:
    25 - 49
Company types
Consultancy
Distributor/Import Export
Licensee
Pharmaceutical company

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    Local literat...
  • Market Access, Launch and Marketing

    Product Market Access, Launch and Marketing

    MEDIPHA SANTE offers a wide range of services which include:Providing all the activities of an “Exploitant” on the French market for French companies or foreign companies that do not have a pharmaceutical establishment in France
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MEDIPHA SANTE resources (1)

  • Brochure Medipha Santé your pharma partner on the French and European market

    With over 20 years of experience on the French market, and now part of Athena Pharmaceuticals group, Medipha Santé can be your partner with tailormade solutions for accessing the FR and EU markets, starting with the market access study, the drafting or auditing of your MA dossier, then assistance with MA approval with FR or EU authorities, all the way to the commercialization, distribution and invoicing of local clients. With our steadily growing expert team, Medipha Santé, your French service provider, have a toolbox full of full-range expertise on every Regulatory, Pharmacovigilance, Exploitant and Quality Assurance aspect of your business.