Menu
Menu
Are you looking for support in the area of regulatory affairs? We have a motivated team of experts on regulatory affairs in Switzerland. We will help you to find your way through the multitude of Swissmedic regulations and instructions. We can advise you on new marketing authorizations, maintain existing authorizations, and evaluate the optimal authorization strategy for you.
Different roads lead to Rome - or in this case to marketing authorization.
Ordinary authorization procedure
Fast-track authorization procedure (FTP)
Temporary authorization
Procedure with prior notification
Authorization according to Art. 13 TPA (taking into account the results of foreign authorization procedures)
Authorization according to Art. 14 para. 1 abis-quater TPA
(similar to "traditional/well-established use")
Marketing authorization requirements differ from country to country. PharmaContext specializes in regulatory affairs and reimbursement in Switzerland. Our experts can advise you with regard to
Meetings/hearings with Swissmedic are possible or necessary for certain marketing authorization procedures. We will help you to submit the relevant applications and - if desired - accompany you to the hearings. If your company does not yet have an establishment license from Swissmedic, we will make our establishment license available to you for the duration of the Swissmedic authorization procedure.
We are happy to support you in maintaining existing marketing authorizations. This includes preparing the following submissions for you:
Variations and change requests (incl. line extensions)
Renewals
Notification of interruption or resumption of distribution
Periodic safety update reports (PSURs) and risk management plans (RMPs)
Transfer of marketing authorization to a new marketing authorization holder
Take advantage of our experience of over 20 years and our in-depth knowledge on marketing authorization applications for a wide range of classes of medicinal products and marketing authorization procedures. These include:
New active substances (advanced therapy medicinal products, biologics, synthetic substances)
Known active substances (with or without innovation)
Special classes of medicinal products such as orphan drugs, anesthetics, herbal medicinal products, radiopharmaceuticals, allergens, etc.
Combination products (medicinal products with medical device components)
We will submit registration documents in the format you require to the Swiss Agency for Therapeutic Products, Swissmedic, via the Swissmedic portal in the format you require (eDok or eCTD). We will create in-house sequences for you for electronic submission to Swissmedic using our eCTD software. We transfer registration documents from the eDok structure into an eCTD sequence (baseline submission).
We are happy to support you to ensure that the launch of your product runs smoothly and will coordinate everything for you:
Publication of the medicinal Product Information texts
Checking the packaging materials before production
Registration of GTIN and Pharmacode, etc.
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.
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
Find out what our customers say about our services