With a global Regulatory framework coupled with expectations to be the powerhouse destination for pharmaceutical manufacturers, Russia offers a good fortune for medicinal product manufacturers to invest in the region. Manufacturers must obtain market authorizations from Federal Service for Surveillance in Healthcare (Roszdravnadzor) to enter the region. With the recently set up Regulatory framework, foreign manufacturers might face challenges navigating through various Regulatory procedures for timely approvals.  

As a specialized global Regulatory partner, Freyr provides expert Regulatory affairs consulting services to assist foreign manufacturers get through the complex mandatory requirements for time-critical approvals. Freyr’s Regulatory services in Russia span across:

  • Medical Devices
  • Pharmaceuticals
  • Biosimilars
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management
  • Regulatory Submissions

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MOH Russia
  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end cosmetic Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market