Quality Assurance

Quality Assurance
Product Description

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)
Batch certification, batch release, batch review
Management of Quality Assurance Agreements with partners (subcontractors, suppliers, manufacturers, distributors)
Contact with partners from a Quality Assurance point of view
Development of Quality Assurance services deliveries activities for Medipha Santé
Planification, realization and follow-up of external or internal Audit
Development of the quality system to comply with the French/EU Pharmaceutical regulation
Contact us for more information.

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MEDIPHA SANTE

  • FR
  • 2015
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
View company profile
Categories
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Specifications
  • Selling Points
    Product Features; Quality Service
More specifications Fewer specifications
Sales Markets
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MEDIPHA SANTE

  • FR
  • 2015
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
View company profile

More Products from MEDIPHA SANTE (5)

  • 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. 
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  • 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...
  • 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
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  • 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...