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REGULATIONS AND STANDARDS

Regulatory standards in Africa are quickly catching up to the rest of the world, so we provide international exposure and experience to keep up with the changes. Our regulatory pharmacists are experts in this dynamic, complex environment.

REGULATIONS AND STANDARDS

 

We have a multidisciplinary team of experts who possess in-depth knowledge in SADC, WHO PQ, and SRA registration guidelines and pathways. The team brings a wealth of experience in the application of GMP, GLP, and GCP guidelines. They take the lead in formulation and development activities across our four fully-fledged F&D facilities.

Our team evaluates a minimum of 100 dossiers annually to assess their compliance with safety, quality, and efficacy requirements. Furthermore, we offer technical support to manufacturers for registration processes and post-registration amendments. We also provide manufacturers with assistance in pharmacovigilance activities.

INTELLECTUAL PROPERTY AND REGULATORY FOCUS

 

Our established local presence across all major SADC (Southern African Development Community) markets enables us to collaborate closely with SADC regulatory bodies. This collaboration allows us to expedite the processing of dossiers concurrently in multiple regions, thereby facilitating faster access to new or enhanced pharmaceuticals and technologies within the region.

The Avacare Devices sub-unit has been actively expanding its product portfolio, with a particular emphasis on diagnostics aligned with the group’s core therapeutic areas, among other priorities.

Our regulatory pharmacists are experts in the dynamic, complex African regulatory environment.

INTELLECTUAL PROPERTY AND REGULATORY FOCUS

Our established local presence across all major SADC (Southern African Development Community) markets enables us to collaborate closely with SADC regulatory bodies. This collaboration allows us to expedite the processing of dossiers concurrently in multiple regions, thereby facilitating faster access to new or enhanced pharmaceuticals and technologies within the region.

The Avacare Devices sub-unit has been actively expanding its product portfolio, with a particular emphasis on diagnostics aligned with the group’s core therapeutic areas, among other priorities.

Our regulatory pharmacists are experts in the dynamic, complex African regulatory environment.