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Beyond Resource is a South African-based regulatory affairs and quality assurance (RA/QA) consultancy. We provide comprehensive compliance solutions for the pharmaceutical, medical device, and In Vitro Diagnostic (IVD) sectors, facilitating seamless market entry through expert navigation of the South African regulatory landscape
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Why Choose Us
Intelligent virtual assistance for business
- SAHPRA Alignment: Our processes are built directly on SAHPRA’s three pillars: Safety, Efficacy, and Quality.
- Local Market Insights: Deep understanding of the South African healthcare environment, including B-BBEE compliance and professional body registrations (SAPC/HPCSA).
- Deadline Readiness: Expert guidance on critical deadlines, such as the 1 April 2025 mandate for medical device ISO 13485 certification.
- Objectivity: We provide unbiased regulatory assessments based solely on scientific evidence and legal requirements, regardless of commercial pressure.
- Transparency: We proactively disclose any potential conflicts of interest that could compromise the impartiality of our regulatory advice or audits.
- Data Privacy: We comply with data protection laws (such as POPIA) when handling client business data or clinician information.
. Broad-Based Black Economic Empowerment (B-BBEE)
As a committed participant in South Africa’s economic transformation, Beyond Resource is a Level 1 B-BBEE company.
- Commitment to Transformation: We actively invest in local skills development within the specialized field of South African regulatory sciences.
- Expertise in Complementary Medicines (Category D)
The South African market for Complementary Medicines (CAMS) and Health Supplements is subject to rigorous oversight under the Medicines and Related Substances Act. We provide guidance on:
- Product Classification: Determining the correct regulatory pathway for Health Supplements.
- Compliance & Labelling: Ensuring labels and marketing claims comply with the strict “General Sales” and “Discipline-Specific” requirements (e.g., Ayurveda, Homeopathy, Traditional Chinese Medicine).
- Audit Readiness: Preparing facilities for SAHPRA inspections to ensure compliance with Good Manufacturing Practice (GMP) for Category D medicines.
- Technical Leadership & Professional Body Affiliations
Our team maintains active standing with key South African professional bodies to ensure the highest standards of ethics and currency:
- South African Pharmacy Council (SAPC): Registered pharmacists providing oversight.
- SAATCA registered SANS/ISO 13485 implementation standards.
Complementary Medicines: manage the Section 14(2) call-up notices, to transition legacy products into the formal SAHPRA registration system.