Regulatory Affairs

Approval procedures at Swissmedic are complex and time-consuming. Existing marketing authorisations also require constant maintenance and updating. We support you in bringing your medicinal products to market, and maintaining marketing authorisations for them throughout their life cycle.


Frequently required services

  • Submissions for new products

    Submissions for new products

    We support you with the submission of marketing authorization applications for medicinal products with new or known active ingredients with or without innovation (generics):

    • Medicinal products for human use

    • Orphan Drugs

    • Synthetics

    • Biopharmaceuticals
    • Radiopharmaceuticals

    • Phytotherapeutic drugs and complementary medicinal products

    • Veterinary Medicinal Products

     

    After defining the correct approval strategy, we prepare the necessary documents:

    • Dossiers in (e)CTD format, Modules 1 to 5

    • Pharmaceutical Quality Dossier, Modules 3 & 2.3 incl. Active Substance Master File (ASMF)
    • Non-clinical dossiers, Modules 4 & 2.4

    • Clinical dossiers, Modules 5 & 2.5

    • EU Drug Master Files (EDMF)

    • CEP applications

     

    We submit applications electronically using the eCTD (Electronic Common Technical Document) tool or as eDoks.

    Upon request, we also provide the following services:

    • Literature searches and preparation of literature-based dossiers
    • Preparation of answers to official questions (e.g. LoQs)

    • Preparation of meetings with authorities (scientific advice, pre-submission, clarification)

    • Co-marketing applications

  • Life Cycle Management

    Life Cycle Management

    In the case of existing approvals, we support you throughout the entire product life cycle with necessary updates of the medicinal product dossier:

    • Major changes (e.g. changes in active substance, change in dosage form or dose strength, etc.)
    • Variation requests with or without scientific evaluation, e.g. related to quality, drug information or packaging material
    • Submission of the PSUR/PBRER
    • Renewing of a marketing authorisation
    • Transfer of a marketing authorisation
    • Withdrawal of a marketing authorisation
  • Strategic consultation

    Strategic consultation

    We would be happy to advise you in the following areas:

    • Development of strategies for obtaining a marketing authorisation
    • Assessment of dossiers (Due Diligence), e.g. in licensing projects
    • Scientific consulting, e.g. for development projects
    • Training of your employees, e.g. for new hires or retraining

     

    If required, we offer the use of our Establishment license to companies without an establishment of their own in Switzerland until they have obtained their own establishment license (e.g. import and wholesale licenses including market release).

Further Services

  • Adaptation of EU dossiers to Swiss requirements

    Adaptation of EU dossiers to Swiss requirements

    Is your product approved in the EU, and are you planning to expand into the Swiss market? We would be delighted to support you with the authorisation process:

    • Adaptation of the EU dossier to the requirements of the Swiss market

     

    If required, we offer the use of our Establishment license to companies without an establishment of their own in Switzerland until they have obtained their own establishment license (e.g. import and wholesale licenses including market release).

  • eCTD – electronic submissions

    eCTD – electronic submissions

    We will also be happy to carry out eCTD publishing for you.

Your contact

Any questions?
I would be delighted to answer them.

Silvia Manser
Head of Regulatory Affairs Services
+41 44 787 70 20
s.manser@pharma-services.ch


 

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Checklist for creating Swiss Module 1 documents.
Swissmedic and the Swiss Federal Office of Public Health (BAG) provide further information:
We have been committed to serving our clients enthusiastically and cooperatively since 1997: