Stop worrying about rejections and costly delays. We provide end-to-end product registration, retention, and compliance solutions directly from Nairobi.
Regulatory Affairs Services in Kenya
Navigate Kenya’s Pharmacy & Poisons Board (PPB) Requirements with Confidence.
Is Regulatory Uncertainty Slowing Down Your Market Entry?
Entering the Kenyan market offers immense opportunity, but the regulatory landscape can feel overwhelming.
• Are you facing unexpected delays with the Pharmacy and Poisons Board (PPB)?
• Are you confused by the strict requirements for Annual Retention?
• Has your dossier been rejected due to technical gaps?
At Jeyflex, we replace anxiety with clarity. We don’t just submit documents; we walk with you through every step of the process, ensuring your products are approved faster and stay compliant.
Comprehensive Regulatory Affairs Solutions for the Kenyan Market
We offer a full spectrum of services tailored specifically to Kenyan regulations for Human & Veterinary Medicines, Medical Devices, and Cosmetics.
01. Product Registration & Market Authorization
- Full dossier preparation and submission (CTD/eCTD formats).
- Fast-tracking submissions for timely market entry.
- Management of queries and responses to the PPB.
02. Lifecycle Management (Retentions & Variations)
- Annual Retention: We ensure your products remain legal for trade by managing mandatory annual retention payments and documentation a common pitfall for foreign companies.
- Variations: We handle all post-approval changes to ensure uninterrupted market presence.
03. Local Technical Representation (LTR)
- Acting as your official liaison on the ground.
- Holding legal responsibility for your product’s compliance in Kenya.
- Coordinating pharmacovigilance and safety reporting.
04. Regulatory Intelligence & Audit Readiness
- Gap Analysis: We assess your existing processes and identify compliance risks before the regulator does.
- Inspection Readiness: We prepare your team for PPB and GMP inspections to ensure you meet national quality standards.
Why Leading Companies Trust Jeyflex in Kenya. We are not just consultants; we are industry insiders.
Navigating Kenya's Regulations
Common Questions About Kenyan Registration
Timelines vary by product type, but our “Right First Time” dossier preparation minimizes query rounds, significantly accelerating the approval process compared to industry averages.
Yes. You require a Local Technical Representative (LTR) to liaise with the PPB. Jeyflex acts as this legal link, ensuring your compliance obligations are met.
Failure to pay retention fees or submit required documents can lead to your product being deregistered and barred from trade. We manage this calendar for you to ensure zero downtime.