Overview

The Republic of Guatemala, a country in Central America, with its tax incentives could be a best destination for medicinal products’ and medical devices’ investments. To access the market, manufacturers must obtain licensing and market authorization approvals from the ministry’s Department for the Regulation and Control of Pharmaceuticals and Related Products which regulates the registration of Guatemalan pharmaceuticals. Though the registration lasts for five years, attaining that would require manufacturers to go through complex set of Regulatory procedures.

Freyr, as a specialized global Regulatory partner with a regional focus, assists foreign manufacturers to decode the Guatemalan Regulatory regime with ease and assists them navigate the procedural challenges. Freyr’s Regulatory services in Guatemala span across:

  • Medical devices
  • Cosmetics
  • Drugs
  • Food
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence,
  • Registration pathways and license management services,
  • Marketing authorization applications, renewals
  • Dossier preparation
  • Pharmacovigilance (RMP, PSUR)
  • CMC Variations

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