REGULATORY
SERVICES

We offer regulatory support with registration procedures and maintenance of approvals for medicinal products, medical devices, food supplements, and infant formulas.

We are centralized at the Medis’ Headquarters in Slovenia and have local regulatory and pharmacovigilance specialists in the EU countries (Austria, Bulgaria, Croatia, Hungary, Slovenia) and non-EU countries (Bosnia and Herzegovina, Kosovo, Macedonia, Montenegro and Serbia) in order to provide personalized attention to our partners' needs.

Our team strengths are enhanced by close cooperation with different departments of Medis and partners such as Quality, Compliance, Sales and Marketing, enabling an "all-in-one-service" for our partners’ products and optimal maintenance through their life cycles.

However complex or simple the regulatory requirements, we are confident of our ability to deliver as a trusted partner and to ensure continuous supply of products to the market.

Contact us directly:
E: regulatory.affairs(at)medis.si 
T: + 386 1 589 69 61
 

Product
Vigilance

Medis offers all the components required for compliant and effective product vigilance to ensure patient safety. We ensure continuous compliance through effectively managing both existing and emerging local regulatory demands. Our reputation and track record has been established through numerous audits and inspections.

Our expertise and networks allow monitoring of the products on the market, identifying and reacting to any new potential safety information. Medis’ regulatory services (including Product safety) help grow and protect our partners, products and involved stakeholders.