Overview

With a booming economy, the Republic of Macedonia attracts foreign medicinal products and medical device manufacturers across the globe for investments in the region. For market entry manufacturers must obtain authorizations from the Macedonian Ministry of Health. Enroute, lack of expert insights on the market and necessary Regulatory procedures might affect their compliance efforts.

Freyr, with an exclusive market insights and authoritative information on the Macedonian Regulatory framework, assists manufacturers to keep abreast with the market updates and navigate through the complex regulatory procedures that range from dossier compilation, regulatory submissions for obtaining market approvals in time. Freyr’s capabilities to provide registration and approval assistance in Macedonia span across:

  • Medical Devices
  • Pharmaceuticals & Bio-Pharmaceuticals
  • Cosmetics
  • Food & Dietary Supplements

Freyr Offerings

  • Strategic Regulatory Consulting
  • Strategic business development focusing on the European market
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Market assessments
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MALNED
  • 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