The Pharma Partner
From market entry to inspection-ready, we handle the regulatory work.
Pharmacist-led regulatory and compliance partner for Kenya and East Africa.
Bridging Regulations & Real-World Operations
The Pharma Partner is a pharmacist-led pharmaceutical regulatory and compliance partner based in Nairobi, Kenya. We carry distributors, manufacturers, and Marketing Authorisation Holders from market entry to inspection-ready, all under one team that stays with you at every stage, inspection day included.
Founded by Florence Wambui, a registered pharmacist with extensive hands-on experience in the Kenyan pharmaceutical sector, we cover product registration, PPB dossiers, pharmacovigilance, quality systems, warehouse compliance, and inspection support, bridging the gap between the rules (PPB guidelines, GMP, GDP) and the realities of daily operations.
"To carry pharmaceutical businesses from market entry to inspection-ready, turning regulatory requirements into systems their teams can run every day, and safeguarding patient safety at each step."
Core Services
Market Entry & Product Registration
Local Technical Representation, PPB product registration, and a clear route from first application to an approved product on the Kenyan market.
PPB Dossiers & Regulatory Affairs
CTD dossier compilation, new drug registration, variations, and PPB submissions managed through to approval.
Pharmacovigilance
QPPV nomination, ADR and PvERS reporting, and a working pharmacovigilance system that meets PPB obligations.
Warehouse & GDP Logistics
Cold chain management, warehouse layout design, and GDP-compliant storage and distribution operations.
Audits & Inspection Readiness
Mock audits, comprehensive gap analysis, and full PPB inspection preparation so you walk in ready.
Training & Capability
Customized staff training and practical courses that build lasting compliance capability inside your team.
Quality Management Systems (QMS)
ISO 9001 quality systems, practical SOPs, and GMP or GDP implementation your team can actually run day to day.
Why Choose The Pharma Partner?
We don't just consult, we partner with you to build systems that last.
100% PPB Audit Success
Every client we've prepared has passed their PPB audit. Our track record speaks for itself.
Pharmacist-Led Expertise
Led by registered pharmacists who understand both the science and the regulatory landscape.
Deep Local Knowledge
Based in Nairobi with intimate understanding of Kenya's pharmaceutical regulatory environment.
End-to-End Continuity
Product registration, regulatory affairs, pharmacovigilance, and QMS aligned under one implementation roadmap.
Leadership Team
Florence Wambui
Founder & Lead Consultant
Registered Pharmacist with extensive hands-on experience in product registration, PPB regulatory compliance, pharmacovigilance, and quality systems across Kenya.
Full profile
Jael Morangi
Pharmacovigilance Specialist
Expert in QPPV (Qualified Person for Pharmacovigilance) nomination, adverse event reporting, and pharmacovigilance system implementation.
Full profileReady to Move From Market Entry to Inspection-Ready?
Book a free 30-minute strategy call today and get a personalized regulatory and compliance roadmap for your organization.