Licensing & Compliance
The varied and dynamic requirements related to compliance for healthcare products and the related expectations that pertain to Good Practices (GxP) pose challenges to the implementation strategies and maintenance of systems.
All companies involved in the manufacture, sale and supply of regulated health products in South Africa require approvals in the form of licences/permits to conduct their operations.
We assist with the following:
- Preparing & reviewing:
- Site Master Files
- Quality Manuals
- Standard Operating Procedures
- Licence Applications
- Licence Renewals
- Pharmacovigilance Master Files
- Acquisition Due Diligences
- Local & Foreign Manufacturer Audits
- Warehouse & Distribution Facility Audits
- Pharmacovigilance Audits
- Advising during the planning stages of activities and envisaged growth or diversification.