Overview

Argentina is an emerging economy offering a good scope for foreign medicinal products and medical device manufacturers to invest in the region. Before entering the market, the investors should obtain necessary approvals and authorizations from the ANMAT or Asociación Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods, and Medical Devices). Enroute, manufacturers might find it difficult to access the Regulatory landscape right from appointing an authorized representative to getting the final health authority approvals.

To assist manufacturers navigate through the complex Argentinian Regulatory landscape, Freyr offers a gamut of Regulatory services inclusive of roadmap strategies, submission preparations, filings and obtaining market authorizations and registrations. Freyr’s Regulatory services in Argentina span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Product assessment and classification
  • End-to-end Regulatory submissions
  • Translational services
  • PSUR
  • Pharmacovigilance
  • Regulatory Audit
  • Dossier compilation
  • Labeling
  • CCDS implementation
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with ANIMAT
  • 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