CAMs & Nutraceuticals

Regulatory and quality consulting for complementary medicines, health supplements, and nutraceuticals. Product classification, dossier compilation, labelling compliance, and facility licensing aligned with SAHPRA Category D requirements.

Determination of regulatory status under SAHPRA's complementary medicines framework (Category D).

Dossier Compilation

CTD-format dossier preparation for herbal, homeopathic, and traditional medicines.

Data Due Diligence

Review of existing data packages and gap identification.

Packaging Compliance

Labels, Professional Information, and Patient Information Leaflets meeting SAHPRA's amended General Regulations.

Claims Management

Permissible health claims assessment and advertising compliance.

Licence Applications

Preparation and submission for import, export, manufacturing, and distribution licences.

Quality Management

QMS design and implementation for complementary medicine facilities.

Testing Oversight

Coordination of identity, potency, purity, and contaminant testing.

Batch Release

QA review, batch record management, and release criteria.

Testing Oversight

Coordination of identity, potency, purity, and contaminant testing.