Overview

With new laws related to Regulatory requirements have come into force, Medicines, Medical Devices and Dietary Supplements manufactures who are willing to enter the Republic of Serbia, are advised to be more vigilant about the regulations and guidelines of ALIMS (Medicines and Medical Devices Agency of Serbia). Apart from the documents need to be submitted in the Serbian language, major challenges manufacturers might face is to compile, submit, and follow-up necessary regulatory requirements for local medicine / device registrations and approvals.

With the proven Regulatory Affairs (RA) and Quality Assurance (QA) experience in the Serbia, Freyr helps manufacturers to navigate the complex registration and approval procedural challenges. Having clear cut understanding of Serbian Regulatory procedures, Freyr can help foreign manufacturers with end-to-end RA consulting for:

  • Medicines
  • Medical Devices
  • Dietary Supplements
  • OTC

Freyr Offerings

  • Strategic Regulatory affairs consulting
  • Dossier preparation, evaluation and submissions
  • eCTD and CTD preparation
  • SMPC, PIL, DFU
  • Labeling, Artwork designing

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MOH, ALIMS
  • Proven RA and QA experience in the region
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market