Tenax Enterprises
Tenax Enterprises (PTY) Ltd is a bold, end-to-end Regulatory Affairs and Quality Assurance Consultancy Firm operating across Southern Africa. We support companies in the Pharmaceutical, MedTech, Complementary & Alternative Medicines (CAMs), Cosmetics, and Cannabis sectors, helping them navigate complex compliance landscapes with confidence. In combining technical expertise with strategic insight, Tenax Enterprises enables clients to reduce costs, accelerate market access, and minimise regulatory risks. Guided by our mantra ,”The Audacity to Try”, we partner with innovators and leaders to achieve growth and compliance excellence.
Main services by Tenax Enterprises
CAMs Quality & Regulatory Support & Services
Compliance Solutions: Adhere to regional CAMs regulations and
safety standards.Quality Control: Ensure consistency and efficacy in herbal,
homeopathic, and alternative products.Market Entry Support: From formulation to approval, we guide you
every step of the way.Labeling & Claims: Mitigate risks with compliant packaging and
marketing materials.
Cannabis Quality & Regulatory Support & Services
Compliance Solutions: Ensure adherence to the Medicines and
Related Substances Act, 1965, for Schedule 7 substances, including
security, testing, and documentation.Quality Control: Design and implement a robust QMS aligned with
SAHPRA’s GAP, GMP (if applicable), and ISO 9001:2015 principles.Market Entry Support: Guide farmers through the entire licensing
process, from application preparation to site inspections.
Cosmetics and MoCRA Regulations, Implementation, Maintenance
& Support
MoCRA Compliance: Navigate new U.S. requirements for safety
and reporting.Global Standards: Align with EU Cosmetics Regulation, ASEAN,
and more.Product Safety: Conduct assessments and ensure ingredient
compliance.Support Services: From registration to post-market obligations,
we’re with you.
Medical Devices Regulatory Support & Services
Global Compliance: Meet SAHPRA, BOMRA, FDA, EU MDR, ISO
13485, and other standards.Risk Management: Implement ISO 14971-compliant processes.
Technical Documentation: Prepare CE marking, 510(k), and PMA
submissions.Post-Market Surveillance: Monitor performance and maintain
compliance after launch.
Pharmaceutical Quality & Regulatory Support & Services
Regulatory Strategy: Navigate SAHPRA, BOMRA, FDA, EMA, WHO,
and other global regulations.Quality Assurance: Optimise processes for GMP compliance and
product safety.Submissions & Approvals: Streamline dossiers, INDs, NDAs, and
post-approval changes.Audits & Inspections: Prepare for and manage regulatory
inspections with confidence.
Tenax Enterprises + Hoodin
Tenax Enterprises and Hoodin are ideal partners, combining advanced regulatory intelligence technology with deep local expertise across Southern Africa. We share the ambition to reduce compliance complexity, support innovation, and create clear value for companies in highly regulated industries.
How Hoodin and Tenax collaborate
Together with Tenax, we strengthen our presence in Southern Africa. Tenax’s technical expertise and strong client relationships, combined with Hoodin’s global Smart Compliance solutions, give life science companies the tools and insights needed to minimise risks, accelerate market access, and ensure sustainable compliance.
Some useful links
Learn more about Tenax Enterprises services