REGULATORY, TECHNICAL AND cGMP SUPPORT

All projects are co-ordinated from our head office in Cape Town. Our highly experienced regulatory and technical team assist with and offer guidance on all regulatory and technical issues related to the compilation and filing of DMFs and CEPs.

Brimchem interacts closely with our customers so as to ensure that we fully understand their specific regulatory and technical requirements and ensure that these requirements are taken into account in the manufacturer’s documentation. In this manner anticipate and can address any technical or regulatory issues upfront and thereby facilitate the regulatory approval process.

All documentation is reviewed by our regulatory team and feedback provided to our manufacturing partner to ensure compliance with international standards and customer requirements. No regulatory documentation is provided to our customer without first being reviewed and approved by Brimchem. Even after commercialization of a product, all COAs of APIs supplied to our customer are first reviewed and approved by our regulatory team.

Brimchem coordinates and assists with the submission of the CEP and/or DMF to all international regulatory authorities and with the regulatory response to any deficiency received.

Staff from our Shanghai office, together with our expert cGMP consultants, conduct regular audits of our API facilities so as to ensure continued compliance with international standards and guidelines.