Regulatory
Affairs
Improving the institutional capabilities, workforce, and processes of NRAs to bolster the effectiveness of inspections and achieve operational efficiency.
Working with manufacturers to achieve regulatory compliance to ensure quality products are produced at all times and customers needs are met.
Designing and implementing AI and data management system to bring greater efficiency and contribute to the maturity of NRAs.
The intricate landscape of international regulatory planning, spanning across 55 diverse African markets, places a formidable demand on both time and resources, necessitating unparalleled expert insight. Our regulatory affairs team stands at the forefront, specializing in the meticulous formulation of highly effective regulatory strategies that seamlessly traverse the entire product life cycle. This comprehensive approach encompasses rigorous feasibility studies and the provision of expert guidance to clients. Our unique value proposition lies in leveraging not only our proprietary intelligence but also the wealth of experience we've garnered within the intricate tapestry of the African market.
Navigating the diverse regulatory landscape on the African continent presents significant challenges for companies seeking product registration. From varying application requirements to complex approval processes and limited clarity on regional harmonization pathways, our Marketing Authorization Support addresses these hurdles comprehensively.
Our team provides end-to-end regulatory operations support, guiding clients through the complete product registration journey. From preparing and submitting applications to addressing regulatory queries and ensuring post-registration compliance, we offer extensive assistance. With expertise spanning small molecules, biologics, ATMPs (such as cell and gene therapies), and IVDs/medical devices, our team brings valuable industry experience, having worked within regulatory agencies or with major pharmaceutical companies.
Our services include:
Recognizing the challenges faced by many African NRAs in regulating the entire supply chain, especially in a globalized world, we are committed to supporting the effective implementation of regulatory harmonization initiatives on the continent. Our services aim to enhance maturity levels within regulatory frameworks.
We collaborate with NRAs in Africa to:
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Loice Kikwai, Ph.D., is the Regulatory Affairs Lead at Market Access Africa. She has over 18 years of expertise in pharmaceutical drug regulation and standardization. She has a background and proficiency in developing standards, evaluating policies and regulations, and educating on global pharmaceutical best practices at various regulatory authorities and industries in the Middle East, Asia, and Africa. Dr. Kikwai's career spans roles at US Pharmacopeia, as a scientist II developing compendial standards, the US Food and Drug Authority (FDA), as a lead pharmacologist specialized in bioequivalence, and at LCK Pharmaceutical Consulting as a consultant specializing in regulatory affairs of generic drug products. Dr. Kikwai is a sought-after speaker at various global conferences that promote, harmonize and strengthen regulations for the safety, efficacy, and quality of generic pharmaceutical drug products. Dr. Kikwai holds a Ph.D. in Pharmaceutical Sciences from Florida A&M University and a B.A. in Biology and Chemistry from Lincoln University, USA.
Sarah Muthuri leads the development of the regulatory practice at Market Access Africa. She has over twenty years of experience in the pharmaceutical industry and was instrumental in the harmonization of regulatory guidelines across the African continent. She has also worked at the International Aids Vaccine Initiative and GlaxoSmithKline Limited, where she held positions in both the Clinical Research field and Regulatory Affairs. Her research lies in Malaria and HIV. Throughout her 20+ years in the Pharma industry, Sarah has been dedicated to ensuring that patients have access to safe and effective drugs. She has been instrumental in the harmonization of Regulatory Guidelines across the continent and takes great satisfaction in seeing a product she registered being dispensed to a patient. She holds a BSc in Chemistry and Biochemistry from Egerton University in Kenya and a Masters in Pharmaceutical Medicine from Hibernia College in Ireland. Additionally, Sarah has completed several leadership courses across Africa, including the Emerging African Leadership program (Stellenbosch University – South Africa) and a Women in Leadership Course (Strathmore University – Kenya).
