Overview

With an advanced healthcare system and an increased drive for innovative healthcare technologies, Slovenia boasts up a good scope for medicinal and medical device investments. To obtain the market access, manufacturers must obtain authorizations from the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP). Entering the region requires successful navigation through complex Regulatory procedures from documentation to submissions and registrations and authorizations.

Freyr, as a specialized global Regulatory partner, provides Regulatory affairs consulting across Slovenia enabling manufactures for in-time product registrations and market authorizations. Freyr’s end-to-end capabilities for Slovenia span across:

  • Medical Devices
  • Pharmaceuticals
  • Cosmetics
  • Food Supplements
  • Biologics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Marketing authorisation applications for MRP and DCP procedures
  • Patient Information Leaflets (PIL)
  • SmPC (Summary of Product Characteristics)
  • Renewal applications and line extension applications (CP, MRP, DCP, NP)

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines