Overview

With a stringent regulatory system for drugs and medical devices which is on par with any regulated markets in LATAM, Paraguay offers the best of business scope for foreign manufacturers.  To enter the region manufacturers must register their products / devices with the Ministry of Public Health and Social Welfare's (MSPBS) management. Though the region has a strong regulatory regime, ever-changing Paraguay’s regulatory pathways might challenge manufacturers to keep pace with the regulatory requirements in-time.

With an expert Regulatory Intelligence team keeping abreast with the worldwide Regulatory updates extensively, Freyr offers medicinal product / device manufacturers the latest of Regulatory requirements in Paraguay. With an end-to-end control over the region’s regulatory scenario, Freyr creates a viable Paraguayan market entry strategy for:

  • Medicinal Products / Drugs
  • Medical Devices
  • Personal Hygiene & Sanitizing Products
  • Cosmetics
  • Food & Dietary Supplements

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory intelligence
  • Standard Operating Procedure (SOP)Development
  • Registration and license management services
  • Dossier preparation, review and management
  • Registers Management (applications, follow-ups, renewals, upgrades, modifications)
  • Verification of regulatory compliance of imported products
  • Verification of compliance of Good Storage practices (GSPs)
  • Tracking and updating new Regulatory requirements and procedures

Freyr Advantages

  • Strategic local Health Authority contacts
  • 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