1. Applicant / MA Holder
PharmaReg acts on behalf of the client as a contract applicant or Marketing Authorisation (MA) Holder, working in liaison with the South African Health Products Regulatory Authority (SAHPRA).
3. Inspections and GMP compliance
- Compilation and review of:
- Site master files
- Standard operating procedures
- Conducting and assisting with:
- Inspections at 3rd party suppliers and vendors
- Local and foreign manufacturer, warehouse and distribution facility audits
PharmaReg also offers its expertise and applications for product registration within the following African nations: Angola, Botswana, Cameroon, Congo, DRC, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi, Mauritius, Mozambique, Namibia, Nigeria, Sudan, Tanzania, Uganda, Zambia and Zimbabwe.
If you’re interested in registering a product within the South African or African market, please complete the Product Specification form here.