Regulatory Affairs

Our regulatory team has extensive experience working with advanced therapies, medical devices, and consumer health products. We collaborate closely with our partners to develop the optimal regulatory strategy, utilizing our extensive knowledge of local regulatory frameworks and our longstanding, trusted relationships with regulatory agencies in Central and Eastern Europe. 

At our headquarters in Ljubljana, our global team coordinates regulatory specialists in local markets, ensuring consistent work quality.

Our team is flexible and can adapt to partners’ needs, whether it involves strategic regulatory counselling or simply providing assistance with the regulatory services we offer:

• Situation analysis (due diligence, gap analysis, audits of dossier documentation)
• Regulatory strategy and applications (DCP/MRP, NP)
• Post-authorization activities (communication with regulatory authorities, linguistic reviews and translations, artwork, regulatory checks of promotional materials)
• Regulatory intelligence and impact assessment

Outsource Your Regulatory Needs to Medis

Central and Eastern Europe is a diverse region with challenging yet promising markets, each with its own specific regulatory system. Outsourcing regulatory services to us allows you to minimize the expenses of an in-house regulatory and pharmacovigilance department.

We can guide you through the complex regulatory landscape, leveraging our expertise, in-depth knowledge of local markets, infrastructure, and resources, efficiently supporting your way of operating as an extension of your team.

Whether you prefer full-scope outsourcing or partial outsourcing of specific regulatory or pharmacovigilance functions, choosing to outsource regulatory services to us offers you the following benefits: 

• Minimize the cost and risk of entering the markets alone
• Optimize resource allocation according to your needs
• Stay up-to-date with the local regulatory requirements
• Focus more on your priorities

With 35 years of experience in handling regulatory projects, highly qualified teams, strong track record, and robust data security, we are well-equipped to meet your needs.