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MEDIPHA SANTE

About MEDIPHA SANTE

Founded 20 years ago as an integrated pharmaceutical services company, Medipha Santé, has excelled in providing a broad spectrum of pharmaceutical services on the European market, which fulfill the needs and aspirations of Pharma Manufacturers and Marketers in EMEA. Thanks to its consultant role and its experience in marketing authorization applications, Medipha Santé provides its knowledge and expertise in regulatory affairs, pharmacovigilance and quality assurance.
Well experienced in the generic drug market, Medipha Santé strives for its customers' success

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  • FR
  • 2015
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
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Products from MEDIPHA SANTE (6)

  • Regulatory Affairs

    Product Regulatory Affairs

    Within regulatory affairs, MEDIPHA SANTE offers a wide range of services which include :application for marketing authorization, monitoring of marketing authorizations, 
    read legibility tests, 
    active substances, translation services. 
    Contact us for more information.
  • Pharmacovigilance

    Product Pharmacovigilance

    MEDIPHA SANTE offers pharmacovigilance services which include : preparation of rmps (risk management plan), 
    ccountability by the begaud method, 
    coding of adverse events according to meddra.
    Medipha Santé can act as local responsible for pharmacovigilance (local qppv) and as a loca...
  • Quality Assurance

    Product Quality Assurance

    MEDIPHA SANTE offers Quality Assurance services which include : 
    Management of quality system documentation
    Management of quality topics  (Complaints, Change Controls , Deviations  CAPAs, Training, Product Quality Review, Quality Indicator, Quality meeting, Risk analysis...
  • Business Development

    Product Business Development

    MEDIPHA SANTE offers a wide range of business development services which include:. 
    Evaluation and assessment of your needsIn-licensing & out-licensing of the product portfolio, 
    optimization of authorized activities
    Market access strategies
    Seeking business and partnership oppo...
  • Marketing Authorization : Exploitation Hosting and Maintenance

    Product Marketing Authorization : "Exploitation" Hosting and Maintenance

    MEDIPHA SANTE offers a wide range of services which include: 
    StrategyCompliance with the requirements for every type of variation
    Preparation of supporting documents
    Submission of variations according to the appropriate procedure
    Renewals
    Pharmacovigilance (Medipha Santé can provide ...
  • 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” company on the French market for French companies or foreign companies that do not have a pharmaceutical establishment in France
    - assistance in the creation of a French subsidiary of your...