What We Do: Guide farmers through the entire licensing process, from application preparation to site inspections.
How We Excel: We draft compliant applications, develop site plans, and ensure security and quality measures meet SAHPRA’s standards, maximising approval success.
Outcome: Secure your cultivation licence swiftly, with zero compliance gaps.
What We Do: Design and implement a robust QMS aligned with SAHPRA’s GAP, GMP (if applicable), and ISO 9001:2015 principles.
How We Excel: Our team crafts non-negotiable SOPs (e.g., Cultivation, Quality Control), Work Instructions, and Forms (e.g., CoA, Inventory Log), ensuring traceability, quality assurance, and audit readiness.
Outcome: A fully compliant QMS that streamlines operations and passes SAHPRA audits with ease.
What We Do: Ensure adherence to the Medicines and Related Substances Act, 1965, for Schedule 7 substances, including security, testing, and documentation.
How We Excel: We conduct gap analyses, implement corrective actions, and liaise with SAHPRA-accredited labs for potency and contaminant testing.
Outcome: 100% compliance with SAHPRA’s regulatory framework, minimising risks of penalties or licence revocation.
What We Do: Develop and install security plans and traceability systems to prevent diversion and ensure full seed-to-harvest tracking.
How We Excel: Our expertise in Schedule 7 compliance includes CCTV integration, access controls, and inventory software tailored to SAHPRA’s requirements.
Outcome: Ironclad security and traceability that safeguards your operation and satisfies regulators.
What We Do: Deliver customised training programs on GAP, QMS, security, and safety protocols.
How We Excel: Our trainers, with backgrounds in pharmaceutical compliance, provide hands-on sessions and competence assessments, ensuring staff readiness.
Outcome: A skilled workforce that upholds SAHPRA standards in daily operations.
What We Do: Conduct internal audits and prepare farms for SAHPRA inspections.
How We Excel: We simulate SAHPRA audits, address non-conformities, and provide real-time support during inspections, leveraging our deep knowledge of PIC/S and GAP standards.
Outcome: Seamless audit success, reinforcing your farm’s compliance credibility.
What We Do: Offer ongoing guidance on cultivation, quality control, and record-keeping to optimise operations.
How We Excel: Our cloud-based tools and dedicated consultants ensure real-time compliance monitoring, from batch tracking to environmental controls.
Outcome: Efficient, compliant daily operations that enhance productivity and quality.
What We Do: Drive QMS enhancements and align farms with international standards (e.g., ISO 9001) for export opportunities.
How We Excel: We analyze performance data, implement CAPA systems, and connect farmers with global pharmaceutical buyers.
Outcome: A future-proof operation ready for local and international markets.
012 807 0392
info@tenaxenterprise.com
70 Vergelegen Avenue, Equestria, Pretoria, Gauteng, 0184
