Regulatory
Affairs

We are committed to revolutionizing regulatory practices for National Regulatory Authorities (NRAs) and streamlining the regulatory pathway for our clients. Our mission is to catalyse a transformative shift in regulatory processes, making them more efficient, transparent, and client-centric.

Sector Expertise

Regulatory Capacity Building

Improving the institutional capabilities, workforce, and processes of NRAs to bolster the effectiveness of inspections and achieve operational efficiency.

Operational Excellence

Working with manufacturers to achieve regulatory compliance to ensure quality products are produced at all times and customers needs are met.

Data Systems

Designing and implementing AI and data management system to bring greater efficiency and contribute to the maturity of NRAs.

What we do

Regulatory Strategy and Roadmap

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.

Marketing Authorization Support

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:  

  • Gap Analysis: Conducting submission-readiness evaluations and offering remediation recommendations.
  • Facilitating Scientific Advice: Organizing pre-IND meetings and scientific advice sessions with regulatory authorities.
  • GMP Audits and Mock Inspections: Ensuring compliance through thorough audits and simulated inspections.
  • Technical Dossier Compilation: Expertise in compiling and reviewing technical dossiers, including eCTD compilation and harmonization as needed across NRAs.
  • Lifecycle Management: Ongoing monitoring of regulatory compliance, managing variations and facilitating the renewal of marketing authorizations.
  • Marketing Authorization Transfer Support: Assisting in the seamless transfer of marketing authorizations.

Organizational Improvement

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:

  • Establish Effective Structures: We assist in setting up structures and systems aligned with strategic ambitions.
  • Optimize and Digitalize Processes: Our expertise extends to optimizing and digitalizing internal processes, including data systems, for increased efficiency.
  • Build Operational Capacity: We focus on building and improving internal operational capacity, fostering a culture of continuous improvement within NRAs.
  • Enhance Organizational Efficiency: Our strategies are designed to enhance overall organizational efficiency, ensuring streamlined delivery of services.
  • Promote Partnerships and Knowledge Sharing: We actively foster partnerships and facilitate knowledge sharing among NRAs, creating a collaborative environment for mutual growth and learning.
Featured Insights
Commentary

Making Markets for Health Care Work: A Conversation with Market Access Africa Managing Partner, Olawale Ajose

In this interview, Market Access Africa Managing Partner Olawale Ajose discusses the role of private markets in enhancing access to healthcare for Africa.

Commentary

Will Global Supply of New Malaria Vaccines meet the African Demand?

Investing in innovation for better tools as well as for rapidly scaling up supply is critical, and it has to be fuelled by the same sense of urgency with which the world developed, produced, and deployed a COVID-19 vaccine

Map of Africa with stethoscope
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Featured Experts

Loice Kikwai

Regulatory Affairs Lead

Loice Kikwai

Regulatory Affairs Lead

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.

Loice Kikwai

Sarah Achola Muthuri

Advisor, Regulatory Affairs

Sarah Achola Muthuri

Advisor, Regulatory Affairs

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).

Sarah Achola Muthuri
Azhee Akinrin
Detail

Azhee Akinrin

Principal, Global Health

Azhee Akinrin
Christian Whiteboy
Detail

Christian Whiteboy

Consultant, Manufacturing and Production

Christian Whiteboy
Courage Matiza
Detail

Courage Matiza

Manager, Policy and Public Affairs

Courage Matiza
Dr Sonia Osi
Detail

Dr Sonia Osi

Senior Associate

Dr Sonia Osi
Judy Wangari
Detail

Judy Wangari

Head of Finance and Client Operations

Judy Wangari
Kareem Adeniji
Detail

Kareem Adeniji

Consultant

Kareem Adeniji
Kudzai Makomva
Detail

Kudzai Makomva

Managing Partner

Kudzai Makomva
Kundai Moyo
Detail

Kundai Moyo

Laboratory Systems and Diagnostic Specialist

Kundai Moyo
Loice Kikwai
Detail

Loice Kikwai

Regulatory Affairs Lead

Loice Kikwai
Marlene Musengi
Detail

Marlene Musengi

Senior Specialist, Pharmaceutical Development and Access

Marlene Musengi
Nancy Njoku-Attah
Detail

Nancy Njoku-Attah

Manager, Commercial Life Science

Nancy Njoku-Attah
Newton Runyowa
Detail

Newton Runyowa

Principal, Diagnostics & Laboratory Services

Newton Runyowa
Olawale Ajose
Detail

Olawale Ajose

Managing Partner

Olawale Ajose
Pam Pillay
Detail

Pam Pillay

Principal, Life Sciences

Pam Pillay
Sarah Achola Muthuri
Detail

Sarah Achola Muthuri

Advisor, Regulatory Affairs

Sarah Achola Muthuri
Tendai Mvuvu
Detail

Tendai Mvuvu

Consultant, Research and Analytics

Tendai Mvuvu
Thierry Sonkoue
Detail

Thierry Sonkoue

Senior Specialist, Diagnostic and Medical Device Access

Thierry Sonkoue
Zipporah Bundi
Detail

Zipporah Bundi

Senior Specialist, Diagnostic and Medical Device Access

Zipporah Bundi
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