Overview

With a Universal Healthcare System and a prosperous Healthcare sector, Romania shows a good fortune to invest for foreign medicine and medical device manufacturers. The market entry requires approvals from the National Agency for Medicines and Medical Devices (NAMMD), which oversees the regulations in the region. Apart from long registration lead-times, lack of knowledge on Romania’s systematic Regulatory mechanism might affect manufacturer’s efforts to get market authorizations.

Freyr as a specialized Regulatory partner, assists foreign manufacturers to effectively navigate through the Regulatory complexities in Romania. Right from recommending systematic Regulatory procedures to executing them with the high-level attention, Freyr helps manufacturers to obtain required market authorizations. Freyr’s Regulatory services in Romania span across:

  • Medical Devices
  • Drugs

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • CE Marking

Freyr Advantages

  • 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