Overview

Promising economic outlook coupled with government’s willingness / commitment to investments in healthcare sector makes Peruvian market offer lucrative business opportunities for medicines and medical devices manufacturers. The pharmaceutical and medical device market in Peru is regulated by Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). Considering the regulator’s newly published amendments to regulatory requirements, foreign manufacturers who are willing to enter the region might face the challenge of managing hidden procedures.

Freyr as a specialized global Regulatory partner and with proven Regulatory Affairs and QA experience, assists manufacturers to navigate through the Peruvian Regulatory guidelines and streamline necessary document preparation and submission activities for timely registrations and approvals. Freyr is capable to provide Regulatory consulting services in Peru for:

  • Pharmaceutical Drug Products (medicines)
  • OTC products
  • Medical Devices
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Dossier Gap Analysis, preparation, review and management
  • Intelligence reports

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