Overview

The progressing economy coupled with growing opportunities for R&D and innovation in life sciences sector makes the Republic of Estonia a haven for medicines and medical devices manufacturers to invest in the region. To enter the Estonian market, manufacturers however must obtain market authorizations from the State Agency of Medicines controlled by Ministry of Health. Navigating the Estonian life sciences Regulatory market might stand a challenging aspect for foreign manufacturers while approaching for necessary registrations and approvals.

Freyr with an extensive knowledge on Estonian Regulatory regime, assists foreign manufacturers with to access the region successfully by providing localized Regulatory insights and operational support. Freyr’s end-to-end Regulatory affairs consulting in Estonia span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • Cosmetics
  • Food & Dietary Supplements
  • OTC
  • Biologics/Biotech

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations and maintenance support
  • Market access consultation
  • Regulatory consultation
  • End-to-end operational support
  • Dossier preparation, review and management
  • Harmonization of Regulatory documents
  • Regulatory Submissions
  • Clinical Trial Applications (CTA)
  • Medical devices and food supplements notifications to Baltic authorities
  • MRP and DCP
  • Native language support for reviewing SPC, PL, Packaging
  • Pharmacovigilance
  • Market assessments
  • In-country representation 

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with State Agency of Medicines of Estonia
  • 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