With a booming economy and with both the domestic and multinational companies equally fulfilling the need of pharmaceutical and medical technology in the country, Brazil boasts a good fortune for foreign medicine and medical devices investors. For market entry, organizations should obtain market authorizations and product registrations from ANVISA (Agência Nacional de Vigilância Sanitária). However, the process involves significant Regulatory challenges right from the requirement of authorized representative to filings to approvals to time-bound license maintenance.

Assisting foreign medicine and medical device investors enter the Brazilian landscape in a compliant manner, Freyr offers complete Regulatory support in the region. As a global Regulatory solutions and services partner, Freyr’s Regulatory services for Brazil span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Due Diligence of Licensing Product Registration Dossiers
  • Market Authorizations
  • Regulatory Strategy
  • End-to-end Regulatory submissions
  • Evaluation and development of DMF
  • Periodic Safety Update Reports
  • GAP analysis
  • Labeling and Packing Insert management
  • Revision and approval of products artworks and promotional materials
  • Post-approval changes
  • Annual Product Review and Renewals
  • Technical and regulatory feasibility evaluation
  • Regulatory review in due diligence
  • Pharmacovigilance
  • Regulatory Audit

Freyr Advantages

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