The regulatory department of Moringa prepares, coordinates, manages and maintains simple and complex regulatory submissions that include initial submissions and re-registrations. It has actively contributed to the development and implementation of regulatory strategy for assigned projects. The department is busy in implementing and effectiveness of the Quality Management System (QMS).
It is an interface with external regulatory groups (e.g., Local Agents, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions. The department has provided regulatory support for developments, manufacturing, post approval etc. and has been instrumental in monitoring the company progress toward fulfilment of regulatory commitments. It has initiated and contributed to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments. It played a key role in the Site registration for GMP audit and renewal of facility licence. The diligence that was required for the pre-inspection audit was meticulous and it facilitated and ensured that all documentation was in-place proved its effectiveness.