Regulatory Expertise

Adverse Event Reporting

Healthcare professionals and patients can report serious problems they suspect may be associated with the medicines and medical technologies they prescribe, dispense, or use to regulatory@kiarahealth.com

Regulatory Expertise

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Global Standards underpins the regulatory principles used by the team of regulatory experts within Kiara Health. These are stringently applied to achieve the goal of marketing authorization of products of the highest quality, safety and efficacy.

Kiara Health enjoys the services of highly skilled regulatory consultants with over 20 years of African Regulatory experience, expertise, tools, leadership skills, insights and successes.

These consultants have been carefully selected based on their multiple achievements in gaining market access for renowned pharmaceutical products spanning a variety of therapeutic areas, within multinational pharmaceutical and prominent generic companies in Africa.

The Kiara Health Regulatory team has a deep and nuanced knowledge of Pharmaceutical Laws and Regulations on the African continent.

Regulatory speed and agility is of the essence in gaining rapid market access and with the necessary skills within the team, Kiara Health has the expertise to navigate an expedited registration process.

The Kiara Health Regulatory team’s expertise lies in not only ensuring the timely delivery of initial dossier submissions for rapid market authorization, but they also understand the importance of dossier submission maintenance to guarantee its lifecycle beyond the period of approval. This is supported by the deployment of our internal core competencies to various Regulatory Authorities across Africa, to assist in expediting approvals and post-marketing surveillance.

The Regulatory team have extensive experience, regulatory expertise and demonstrated successes in handling regulatory authority recommendations and/ or challenges, including a variety of pre- and post-marketing concerns.

Kiara Health can therefore confidently offer our regulatory intelligence and insights, together with the science from our partners, to the African continent.