Regulatory Affairs Support
With our in-depth knowledge of local regulatory processes and interaction with local health authorities, we ensure the fastest availability of medicines for every patient in need.
We have the expertise to support the importation of both registered and unregistered medicines.
Medis is known as a pharmaceutical company with impeccable ethical and quality standards, recognized also by the local Regulatory Authorities of the area.
We provide regulatory and pharmacovigilance services for more than 150 INNs throughout Medis’ territory, for more than 93 pharmaceutical (EU and US) companies.
Our central headquarters are located in Slovenia and we have local regulatory and pharmacovigilance specialists both in EU countries (Austria, Baltics, Bulgaria, Croatia, Hungary, Slovakia, Slovenia) and non-EU countries (Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, and Serbia).
This allows us to provide personalized services for your medical marketing needs in each local market specifically, while maintaining the same working standards regardless of the regions covered.
Regardless of how complex or simple the regulatory requirements are, we are confident that we can deliver results as a trusted partner. Nonetheless, Medis regulatory staff is experienced, reliable, and flexible, and has been with Medis for more than 12 years on average.Urša KlunManaging Director Regulatory Affairs Division
The Regulatory Affairs team is flexible in terms of organization and optimization of processes to adapt to partners’ needs.
Our team’s existing strengths are bolstered by close collaboration with Medis' Quality, Compliance, Marketing, and Sales departments.
With such synergies, we can provide you with all-in-one service for all your products and optimal maintenance schedules throughout their life cycle.
What our partners say about us
They have built a team with rhythm with collaboration at the very heart of everything they do. It’s a pleasure to work with such a great group of individuals who really understand what we do."
Marketing Lead MS IPM
Director, Strategic Business Partnerships Management (EMEA)
Director Sales Europe Third Party, Hospital Care Division
Regional Head of the Central/Eastern Europe and the CIS at Besins Healthcare, Russian Federation
Head of Established Brands, International Markets
I think we were growing scientifically together, because your colleagues were always coming back to us with difficult questions regarding product, substances, compositions, applications, that really helped us. Thirdly because of your great employees that are dedicated to our brand. We only wish to have partners like Medis in other countries! So wherever Medis is going in the future – you can count on us as well."
Founder of Pleuran
With Medis we have a long term partnership, a tradition and we respect that. Also it is great that one company has affiliates in different countries, so this model is most optimal for further collaboration for our Gengigel products."
Founder and President of company Ricerfarma