Overview

To enter South Africa, foreign medicines and medical device manufacturers must comply with the regulations formed by the South African Medicines Control Council (MCC). However, with a recent legislation to form a new regulatory agency, the South African Health Products Regulatory Agency (SAHPRA) for regulating drugs, biologics, medical devices, in vitro diagnostics, and complementary medicinal products, food, and cosmetics might create some procedural challenges for manufacturers to go for registrations and obtain necessary approvals.

Addressing the manufacturers growing concerns over the new Regulatory agency and required procedures for successful registrations and approvals, Freyr as an exclusive global Regulatory partner offers exclusive Regulatory affairs consulting services. Freyr’s Regulatory services in South Africa span across:

  • Pharmaceuticals
  • Medical Devices
  • Biologics / Biotech
  • Food and Dietary Supplements
  • OTC
  • Veterinary

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Complete Life Cycle approach to CTD / eCTD dossier compilation and Publishing
  • Dossier preparation, review and management
  • Regulatory Submissions eCTD/CTD, NeeS
  • Medical Writing

Freyr Advantages

  • Strategic local Health Authority contacts – with Ministry of Health
  • 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