8+
Service specialisms
Global
Regulatory Reach
GMP
Regulatory Reach
ISO
13485 · 22716 · 9001
Ready
Aligned
Service specialisms
Regulatory Reach
Regulatory Reach
13485 · 22716 · 9001
SAHPRA, BOMRA, MCAZ, ZAZIBONA
EMA · WHO · EU
FDA, MoCRA, 510(k), NDA/IND
SFDA, MOHAP UAE, GCC
Regulatory strategy, registrations, GMP compliance, and pharmacovigilance for medicines and biologics.
SAHPRA licensing, GAP compliance, QMS development, and seed-to-harvest traceability for medicinal cannabis.
Classification, registration, ISO 13485 compliance, and post-market surveillance for devices and diagnostics.
Product classification, dossier compilation, labelling compliance, and market entry for complementary medicines.
ISO 22716 GMP, MoCRA compliance, ingredient safety assessments, and global cosmetic standards.
FSSC 22000, HACCP, labelling compliance, and regulatory support for food and beverage manufacturers.
One partner covering your full life sciences portfolio
SAHPRA, BOMRA, FDA, EMA, WHO, ZAZIBONA, and beyond.
From strategy and submissions to audits, training, and ongoing compliance.
Trusted by pharmaceutical manufacturers, cannabis cultivators, device companies, and cosmetic brands.
We guide your business through every stage of the regulatory approval process across multiple markets.
Design, implement and maintain robust quality management systems built for long-term compliance.
Navigate licensing, approval and market access requirements — from first application to successful launch.
012 807 0392
info@tenaxenterprise.com
70 Vergelegen Avenue, Equestria, Pretoria, Gauteng, 0184
