Your partner for regulatory approval and market access.
From concept to commercialization, we are dedicated to supporting your product development journey by providing you with the expertise and guidance you need to successfully navigate the complex and ever-changing landscape of global regulations to achieve regulatory approval and market access for all of your healthcare products.
DEVELOPMENT PROJECTS
REGULATORY APPROVAL
LEGAL RESPONSIBILITIES
CH-REP
Our Product Expertise
MEDICAL DEVICES
MEDICINAL PRODUCTS
COSMETIC PRODUCTS
FOOD / FOOD SUPPLEMENTS
Our Services
regenold swiss offers an array of regulatory services and consultancy to medical device and pharmaceutical companies from Switzerland or foreign companies intending to enter the Swiss market:
- Supporting the whole product lifecycle from product development strategies to post-market surveillance.
- Providing specialized medical device expertise, e.g. for biological evaluation, clinical evaluation or compilation of technical documentation.
- Particular focus on borderline products (medicinal product/medical device/cosmetic product) and combination products (medical device + medicinal product).
- Proven track record with software as medical device.
- QMS support for GMP/GDP or ISO 13485/MDR compliance.
- Auditing services.
Local Expertise
regenold swiss takes over local legal responsibilities for the Swiss market, temporarily or permanently, and acts as your contact towards Swiss authorities:
- regenold swiss primarily offers Swiss Authorized Representative (CH-REP) services for foreign medical device manufacturers wishing to market their devices in Switzerland.
- Vice versa, we can offer EC-REP and UKRP services for Swiss exporting companies through other subsidiaries of the regenold group.
- regenold swiss supports pharmaceutical companies in fulfilling local legal responsibilities (RP/FvP) and setting up business entities in Switzerland.
Who needs a CH-REP?
Any manufacturer of medical devices or in-vitro diagnostic devices (IVD) based outside of Switzerland that wishes to place their product on the Swiss market must designate a Swiss Authorised Representative (CH-REP).
The CH-REP takes the local responsibility for formal and safety-related aspects connected with the placing on the market of the device, for example confirming that the conformity assessment procedure has been carried out, or ensuring that any serious incident reports are sent to Swissmedic.
Our regenold swiss office and experts can cover this role for you. Get in contact with us for further information about our services.
Why Choose Us?
Sound & reliable foundation: regenold swiss is part of the Regenold group of companies, founded by Dr. Jürgen Regenold in 1994.
Broad knowledge: we can cover all aspects of Medical Devices, IVD, Drugs, or Drug Combination Products.
Network: we can build on regenold’s proprietary network regulanet®, consisting of partners in over 90 countries worldwide.
Local presence: we ensure compliance with local regulations and developments, also being a member of Swiss Medtech.