Overview

With an improved fiscal performance, and with a universal health care system, Greece offers good investment opportunities for medicine and medical device manufacturers. Accessing the market requires manufacturers to obtain necessary approvals from The National Organization for Medicines, an entity of Ministry of Health and Social Solidarity. Right from informing the Greek National Organization for Medicines (EOF), manufacturers might have to cope with other complex Regulatory procedures for registrations and licensing.

Freyr, as a Global Regulatory Solutions and Services provider, assists foreign manufacturers to be abreast with the Greece Regulatory regime for successful compliance and timely approvals as well. Freyr’s end-to-end Regulatory affairs consulting for Greece span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • OTC
  • Biologics
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Dossier preparation, review and management
  • Regulatory Submissions
  • PSUR Preparation
  • Pharmacovigilance
  • In-country representation 

Freyr Advantages

  • Strategic local Health Authority contacts – with National Organization of Medicine
  • 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