Dr. Elly Onyango Obonyo
Technical Director (EAC & IGAD)15+ years in pharmaceutical regulatory affairs, market access and entry. Based in Nairobi, Kenya.
Regulatory excellence across Africa
Regulatory certainty for medicines across Africa.
ECP is your trusted partner for regulatory intelligence, clinical research, pharmacovigilance and cGMP support across African markets. Nairobi-based experts with 15+ years of experience.
15+Years experience
25+Countries served
100+Projects completed
Nairobi · Est. 15+ years
Seven disciplines. One partner.
Trusted by GSK, Novartis, Merck & 22+ global pharma leaders
01 What we do
Comprehensive regulatory and clinical solutions, built for African markets.
01
Strategic Regulatory Intelligence
Stay ahead of evolving regulatory environments in African markets with strategic intelligence.
02Regulatory Affairs
Comprehensive regulatory affairs management, from new product authorisations to lifecycle management.
03Clinical Research
Clinical trial support, site selection, regulatory approvals and pharmacovigilance services.
04cGMP Compliance
GMP audits, quality system implementation and preparation for regulatory inspections.
05Regulatory Medical Writing
Clear, concise and compliant regulatory and medical writing, delivered by expert writers.
06Labeling & Artwork
End-to-end labeling services and comprehensive solutions for artwork management.
07Pharmacovigilance
Drug safety and efficacy assured through comprehensive pharmacovigilance services.
02 Who we are
Your partner in African pharmaceutical excellence
Headquartered in Nairobi, Kenya, ECP is a private limited company incorporated under the Companies Act 2015.
We are a consortium of professionals with over 15 years of experience in assisting global pharmaceutical companies in achieving regulatory compliance, clinical research, and cGMP standards.
Our vision
To be the premier provider of end-to-end regulatory solutions and clinical research services in Africa.
Our mission
To streamline the expensive and time-consuming process of bringing effective and reliable medicines to market and ensuring their continued availability for the benefit of patients.
i.
Extensive experience
With over 15 years of expertise, we have a proven track record of helping global pharmaceutical companies achieve regulatory compliance, clinical research excellence and cGMP standards.
ii.
Proven success
ECP has completed numerous projects with leading pharmaceutical companies, delivering successful outcomes in regulatory intelligence, clinical trial label knowledge and marketing authorization transfer.
iii.
Specialised knowledge
Our multidisciplinary team specialises in end-to-end regulatory solutions, with in-depth knowledge of the standards of African Medicines Regulatory Authorities (AMRAs).
iv.
Commitment to innovation
We are dedicated to shortening the expensive and time-consuming process of bringing effective medicines to market, so they reach patients quickly and stay available as long as they benefit public health.
v.
Client-centric approach
We prioritise our clients’ needs and tailor our services to their specific requirements, fostering long-term partnerships and successful outcomes.
vi.
Regional expertise
Headquartered in Nairobi, we have a deep understanding of the regulatory landscape in Africa, with targeted solutions for the unique challenges of each market.
A consortium of industry experts
Built to the standards of African medicines regulators.
We provide our clients with a comprehensive portfolio of services optimised to meet the standards of African Medicine Regulatory Authorities.
15+Years experience
25+Countries served
100+Projects completed
100%Compliance rate
03 Track record
Successful approvals and research projects across Africa.
20152017-20192016-20172017-20182018
Grünenthal Pharmaceutical Project
Provided regulatory intelligence and guidance for branded generic registrations and regulatory maintenance in Kenya.
World Bank - EBA Project
Delivered regulatory framework intelligence for the Efficient Business for Agriculture (EBA) project, impacting veterinary product registration and importation in Kenya.
GSK Projects
Supported PAREXEL's GSK Vx Divestment project, regulatory strategy for Kenya and Nigeria, and restructuring of pharmaceutical operations in Sub-Saharan Africa.
PAREXEL Multi-Client Projects
Provided consulting services for Novartis, Merck, P&G, Angelini, MSD and LEO Pharma including clinical trial label knowledge and regulatory strategy development.
Health Advances Boston
Conducted regulatory intelligence for vaccine development and regulatory strategy in Ethiopia, Nigeria, and the Democratic Republic of the Congo.
04 Pan-African footprint
Where we operate.
Select a region or hover a country to see our local expertise and team coverage across Africa.
Countries served
05 Leadership
Experienced professionals with deep expertise in African regulatory landscapes.
06 Insights & whitepapers
All insights Regulatory intelligence for Africa.
Why the African Medicines Regulatory Authority (AMA) Changes Everything for Pharma Strategy in 2025
The African Medicines Regulatory Authority became operational this year, ushering in a continent-wide framework that will reshape how marketing authorizations are pursued across the 55 AU member states. We examine what this means for product launch timelines and where the transitional windows remain.
8 min readRead article
Preparing for WHO PQ Inspections: A Practical Audit Checklist for East African Manufacturers
WHO Prequalification audits remain the gold standard for accessing donor-funded tenders across EAC and SADC markets. Drawing from recent inspection experiences across Kenya, Tanzania and Uganda, our team breaks down the 14 most common deficiencies and how to address them before the inspector arrives.
12 min readRead whitepaper
Building a PV System That Scales: Lessons from Multi-Country Rollouts Across ECOWAS
Pharmacovigilance obligations vary widely between Nigeria’s NAFDAC, Ghana’s FDA and the Francophone regulators. We map the practical differences, the shared reporting templates that work everywhere, and how to staff a PV hub that serves the entire West African region without duplicating effort.
10 min readRead article
07 Client perspectives
Trusted by the world’s leading pharmaceutical organisations.
ECP's strategic guidance was pivotal in navigating the complex regulatory landscape for our vaccine rollout in East Africa. Their local expertise is unmatched.
The team's deep understanding of AMRA standards accelerated our clinical trial approvals significantly. A truly professional and reliable partner.
ECP has been an invaluable asset for our pharmacovigilance operations across the SADC region. Their attention to detail and compliance is outstanding.
Efficient, professional, and deeply knowledgeable. ECP streamlined our product registration process in Nigeria and Ghana.
Their intelligence on the evolving regulatory framework in Kenya gave us a competitive edge. Highly recommended for any pharma company entering Africa.
Comprehensive support from labeling to post-market surveillance. ECP is our go-to partner for regulatory affairs in Africa.
08 Digital documents store
Regulatory resources & templates.
Access ready-to-use regulatory documents, intelligence reports, and templates for African markets.
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Contact us
Ready to navigate Africa’s regulatory landscape?
Partner with ECP for expert guidance in regulatory intelligence, clinical research, and compliance across the continent.
Start a conversation- Headquarters1st Floor, Rm 29A, Vision Plaza
Mombasa Rd, Nairobi, Kenya
P.O. Box 6442-00300, Nairobi - Call