Marketing Authorization : "Exploitation" Hosting and Maintenance

Marketing Authorization : Exploitation Hosting and Maintenance
Product Description

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 the function of “local QPPV”)
Management of the sunset clause (AMM)
Literature watch
Regulatory monitoringImplementation of Safety Data Exchange Agreement (SDEA)
Maintaining the local PSMF
Maintenance of opening authorizations, BPD certificate
Contact us for more information.

MEDIPHA SANTE

  • FR
  • 2015
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
Specifications
  • Selling Points
    Product Features; Quality Service

MEDIPHA SANTE

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

More Products from MEDIPHA SANTE (4)

  • 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 local r...
  • 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) q...
  • 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 opportu...