• PharmaContext GmbH, Haldenstrasse 5, CH-6340 Baar

Market access for pharmaceutical products in Switzerland

We will accompany you every step of the way

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Establishing a pharmaceutical branch in Switzerland

Operating license and regulatory support included

Are you planning to distribute medicinal products in Switzerland but do not yet have a branch in Switzerland? No problem - we can help you to establish a pharmaceutical company in Switzerland. We will provide you with our establishment license during the start-up phase so that the marketing authorization application for your medicinal product can be filed at Swissmedic in parallel.

Foundation of a company office

If you wish to obtain market access for your medicinal product in Switzerland, your company must have a branch in Switzerland. Together with our partners, we will help you find an attractive location for your branch and take care of the necessary legal and administrative formalities.

PharmaContext establishment license

The Swiss Agency for Therapeutic Products, Swissmedic, only accepts marketing authorization applications from companies that have a Swissmedic establishment license. PharmaContext is in possession of such an establishment license from Swissmedic for the import, export and wholesale trade for medicinal products, including market release, as well as for the handling of controlled substances and narcotics. In order to make use of the time during which you establish your branch in Switzerland, we can offer you the option of registering your product with Swissmedic under our name or by means of our establishment license:

We will advise you on the strategic orientation and the best possible choice of marketing authorization procedure.

We will prepare the application for marketing authorization for submission to Swissmedic.

We will handle the correspondence with the authorities in consultation with you.

We will accompany you through the marketing authorization process up to the issue of the registration certificate, and beyond that during the entire life cycle. 

We will transfer your authorization as soon as you have received an establishment license from Swissmedic, ideally during or before completion of the marketing authorization procedure.

Obtaining an establishment license

A company wishing to import, export, distribute or manufacture medicinal products or trade them abroad from Switzerland must have an establishment license from Swissmedic.
We will be happy to assist you with

establishing your quality management system

submission of the marketing authorization application to Swissmedic

preparing for the inspection and follow-up

contributing toward the inspection with our expertise

On request, a qualified specialist from our team can take on the role of the responsible person (RP) in your company to bridge short-term staff shortages or as a long-term solution.

Non-binding inquiry

Long-term support

You have established your subsidiary, the inspection has been successfully completed by Swissmedic and Swissmedic has issueed the establishment license for your company. In the meantime, your medicinal product has received marketing authorization from Swissmedic and you have reached an agreement with the FOPH regarding the conditions for reimbursement. Now nothing stands in the way of successful market access for your medicinal product in Switzerland.
Even after a successful market launch, we will be at your side as a long-term and reliable partner when it comes to matters relating to regulatory affairs, quality assurance and pharmacovigilance, as well as compliance with and implementation of the Swiss Therapeutic Products Act.
Non-binding inquiry

Contact us without obligation

Benefit from our wide range of services, our expertise and our many years of experience.
We are committed to making your projects a success in a professional, practice-oriented and time-optimized manner.

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What sets us apart

Over 20 years of experience that pays off for you.
We fully identify with your project and will find the optimum solution for you.

More than 20 years of experience as a pharmaceutical service provider

Excellent quality of work

Commitment and motivation

Professionalism

Focus on your needs

Everything from a single source

Customer opinions

Find out what our customers say about our services

I would like to thank you very much for your professionalism during today's audit and for your very good work, which led to today's successful audit. I am very happy to have PharmaContext as a service provider who really takes the work off my hands and carries it out reliably.
Thank you once again.
(June 2024)
Wow - PharmaContext Service, thank you very much for that.
(June 2024)
I would simply like to congratulate you! Once again, you have demonstrated your phenomenal knowledge and experience to me and our company.
(October 2023)
Congratulations on another successful inspection. Even from a distance it was obvious that things went smoothly and I'm sure all your preparations made this possible! You are a treasure to us!
(September 2023)
Working with you and the team is a pure pleasure; thank you for the excellent collaboration as well as for your deep expertise and passion to successfully bring so many values to Switzerland!
(September 2023)
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Put your pharma project in the hands of experts. Contact us now to realize your plans.

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