Regulatory Affairs and Pharmacovigilance

Pharmaceutical products and Medical devices are highly regulated in most countries in order to protect public health. These regulations are in place to ensure that the products meet appropriate quality, safety and efficacy standards.

The Regulatory & Pharmacovigilance Department is responsible for obtaining marketing authorizations, ensuring that the approved registration dossiers for all product categories (medicinal products, cosmetics, food supplements, medical devices) are always valid and up-to-date, as well as the functioning of the system for the detection, assessment, understanding, and prevention of adverse reactions or other issues that may be relevant to medicinal products.

The team of regulatory and pharmacovigilance specialists has vast experience in conducting regulatory approval processes and pharmacovigilance activities in the Kenyan Market.