MEDIUS AG - DRUG REGULATORY AFFAIRS SERVICES SWITZERLAND
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Our solution for market entry

If you are an international company, with no subsidiary in Switzerland, your partner Medius can act on your behalf.
Various options are possible:
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Contact us to develop the best strategy for your success.
Application for the Marketing Authorisation by Medius
  • Preparation of Swiss specific application file.
  • Timely submission and liaison with Swissmedic.
  • Professional support / management of registration procedure from pre-submission, submission to MA approval and post-approval.
  • Launch support.
Medius is the holder of an establishment license. As your partner we can apply for the Marketing Authorization on your behalf.
Holding of the Marketing Authorisation by Medius
- or -
Medius acts as Operational Site
  • Provide Responsible Person and deputy according to Swiss law (FvP).
  • Establishment and maintenance of local Quality Management System and contract management.
  • Release of batches to Swiss market.
  • Provide local Responsible Person for pharmacovigilance.
  • Preparation, attendance and follow-up of Swissmedic Inspections.
  • Liason with pre-wholesaler.
  • Supervision of distribution, performing audits.
  • Professional handling and reporting of adverse events, quality complaints and medical queries.
  • Drug regulatory affairs Life Cycle Management.
Medius can act as the licence holder on long-term or as interim solution.
Transfer of the Marketing Authorisation by Medius
If Medius acts as the license holder:
  • transfer of the Marketing Authorization to your subsidiary can be initiated at any time.
  • Medius prepares the transfer if you buy an existing Marketing Authorization. 
Medius can act as the licence holder and transfer the licence any time as required 
by your company.

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Further services offered by Medius

You may profit also from the significant experience in other activities: 
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We are pleased to support you in developing the best strategy for your products in licensing and new market opportunities.  

Contact us
Medius AG
Drug regulatory affairs and development
Neue Bahnhofstrasse 160
4132 Muttenz
Switzerland

+41 61 465 70 40 - Phone
+41 61 465 70 41 - Fax
welcome@medius.ch

Office Hours
Mo - Fr
08.00 am - 05.30 pm
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Relevant Swiss law and ordinances
Federal Act on Medicinal Products and Medical Devices
​Ordinance on Licensing in the Medicinal Products Sector
​

Swiss competent authorities
​Swissmedic
Federal Office of Public Health

USA
FDA - USA Food and Drug Administration

EU
European Medicines Agency

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  • Home
  • Team
  • Services
    • Areas of Expertise
    • Market Entry
  • Experience
  • Customers
    • Client Profile
    • Client Satisfaction
    • Downloadarea
  • Career
  • Newsblog
  • Contact
    • Imprint
    • Privacy
    • Privacy note PV, MI and PC