Overview

South Africa is among the advanced nations in the African continent. The country offers good demand for import of Health Supplements, making it a dependable market. These products are governed by South African Health Products Regulatory Authority (SAHPRA) in the country. The Self-Medication Manufacturers Association of South Africa (SMASA) represents and supports companies involved in the manufacturing, sale, distribution and consultation of healthcare products (including over-the-counter (OTC) and complementary medicines).

As products are classified based on low-risk or high-risk and submission of registration applications must be done in latest version of the Common Technical Document (ZA-CTD) format, you might require professional Regulatory assistance.  

Freyr offers full-scale Regulatory support including product classification, notification, submission in CTD format (for registration), ingredient analysis and others. In addition, Freyr extends gap analysis for documents to ensure compliance across all segments of submission and legal representation services. 

Freyr Expertise

  • Product Classification
  • Ingredient Analysis
  • Label & Claims Review
  • Gap Analysis of Documents for Compliance
  • Legal Representation Services
  • End-to-end Registration Support

Freyr Advantages

  • End-to-end Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with different Health Authorities