Regulatory Affairs

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 90 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

Partner with us for a streamlined and successful commercialization journey. 

Get in touch with our business development team for partnering opportunities.

Contact us.

Medis, d.o.o. Brnčičeva 1, 1000 Ljubljana