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
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.


  • FR
  • 2015
    On CPhI since
  • Selling Points
    Product Features; Quality Service


  • FR
  • 2015
    On CPhI since

More Products from MEDIPHA SANTE

  • 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 reference person on behalf of foreign companies and 
    carry out a watch of the local literature within the framework of pharmacovigilance. 
    Contact us for more information.
  • e-CTD

    Product e-CTD

    MEDIPHA SANTE offers a wide range of eCTD services which include:creating e-ctd sequences, 
    submiting to the french and european authorities (40 files already submitted and evaluated by 25 agencies), 
    ensure the evaluation of the file during the procedure (additional file, admissibility, answers to the im and pr, answers to the questions during the different stages of the calendar.), 
    submitting post-ma applications (change requests, renewals). 
    Contact us for more information.
  • 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 opportunities, e.g., helping manufacturers find distributors and vice-versa
    Specialised professional advice, for example on registration and MA (Marketing Authorisation) dossiers
    Support for the development of your activities or product portfolios
    Search for potential licence holders for customers’ own products
    Project management
    Drafting of various contracts (for the provision of services, licensing and delivery, mandates, etc.)
    Contract negotiation
    Drafting offers
    Search of active substance sources
    Contact us for more information.
  • 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 pharmaceutical company, with the “Exploitant” status
    - preparation, submission and follow-up of price and reimbursement files with the HAS and the CEPS for pharmacy or hospital medicines
    - tender management for hospital products : 
    - turn-key offer including distribution via a qualified French pre-wholesaler, pharmacovigilance, medical information and local quality assurance activities
    - set-up product specifications with manufacturers or logistics partners,
    - certification of the sales forces and assistance for their supervision on the regulatory level in terms of French legislation,
    - management of the local quality assurance (QA) environment during product launch and distribution,
    - medical information management by a team of scientists and pharmacists trained and supervised by a physician
    _ providing local Pharmacovigilance representatives or a Local Qualified Person (LQP) on the basis of the legal requirements of the concerned member state (CMS).

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