Overview

With a growing demand for the imported medicines reflecting the government’s efforts to regulate the pharma sector, Venezuela offers a great deal of opportunities for foreign medicine or medical device manufacturers. However, to get the Venezuelan market access, pharmaceutical companies must obtain market authorizations from MPPS (Ministry of Health) - The Ministerio del Poder Popular para la Salud (for medical devices The Servicio Autonomo de Contraloria Sanitaria [SACS] and The Instituto Nacional de Higiene Rafael Rangel [INHRR]). Enroute, right from requiring an authorized representative, organizations might have to undergo complex regulatory procedures for successful registrations and authorizations.

Freyr, as an exclusive global Regulatory partner, assists organizations to keep abreast with the Venezuelan regulatory market changes and for preparation of local dossier documentation for submissions and approvals of new registrations and authorizations. Freyr’s exclusive Regulatory services in Venezuela span across:

  • Medical Devices
  • Pharmaceuticals
  • Cosmetics
  • OTC
  • Food & Dietary Supplements
  • Natural Products

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Product registrations and CMC changes
  • Maintenance and product renewals
  • Regulatory Submissions and Publishing
  • Common Technical Documents (CTDs)
  • Periodic Safety Update Reports (PSURs)
  • SmPC, Patient Leaflet, Labeling
  • CMC change control

Freyr Advantage

  • Strategic local health authority contacts – with MOH, INHRR
  • 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