We have qualified molecular biologists working in the department with two major functions of regulatory and compliance, the sub functions are outlined below:
- The regulatory department is responsible for obtaining approval for new MDX products and ensuring that approval is maintained through annual retentions.
- The regulatory department acts as the channel of communication between the regulatory authorities and our principal companies.
- The regulatory department is responsible for informing on the current legislation, guidelines and other regulatory intelligence, the department offers advice accordingly.
- The central tenet of our compliance department is to be proactive and this is achieved by ensuring that all our processes adhere the PPB ,KMLTB and Manufacturer’s guidelines.
- The regulatory department ensures that the laid down SOPS are followed to meet regulatory objectives.
- The regulatory department superintends molecular diagnostics and all safety reports.