What We Offer
Comprehensive regulatory affairs services designed to move your products from concept to market — efficiently, compliantly, and with confidence.
End-to-end management of product registration with Kenyan and East African regulatory bodies including PPB, KEBS, and KPRA. We handle all documentation, submissions, follow-ups, and liaison with authorities to secure your market authorization certificates.
We compile, review, and format complete technical dossiers to the required standards — CTD format, ACTD, or authority-specific formats. Our team ensures every document meets the scientific and administrative requirements before submission.
Before investing in full submissions, we conduct thorough regulatory intelligence assessments. We identify gaps in your product documentation, flag potential issues, and design a strategy that minimizes risk and timeline.
We review product labels and packaging artwork against applicable regulations — checking claims, mandatory information, language requirements, and format compliance — for all three product categories.
Regulatory obligations don't end at approval. We provide ongoing post-market support including adverse event reporting, certificate renewals, variation submissions, and periodic safety updates.
We offer customized training programs for in-house regulatory, quality, and marketing teams — covering regulatory frameworks, GMP principles, documentation best practices, and EAC standards.
We manage the regulatory side of cross-border trade — securing import permits, certificates of free sale, GMP certificates, and coordinating with customs authorities for regulated products.
We support companies in implementing and maintaining quality systems compliant with ISO 13485 (medical devices), ISO 22000 (food safety), and GMP standards required by regulatory authorities.