Expert regulatory consulting for Common Technical Document (CTD) compilation, review, and submission to Kenya's Pharmacy and Poisons Board (PPB) - for pharmaceuticals, biologics, generics, medical devices, and cosmetics.
MedWisdom Lifescience Pvt. Ltd. is a globally recognized regulatory consulting firm offering end-to-end CTD dossier preparation, writing, and review services for Kenya. We support pharmaceutical manufacturers, importers, exporters, and life sciences organizations in achieving full compliance with the Kenya Pharmacy and Poisons Board (PPB) registration requirements.
The Common Technical Document (CTD) is the internationally harmonized format mandated by the International Council for Harmonisation (ICH) for submitting pharmaceutical marketing authorization applications. In Kenya, the PPB - the country's principal regulatory authority for health products - requires CTD-format submissions for the review and approval of all medicines, generics, and biologics.
The CTD format is structured into five modules, each addressing distinct regulatory requirements. Understanding these modules is essential for any organization seeking drug product registration in Kenya. MedWisdom's regulatory experts ensure that every module is accurately compiled, scientifically rigorous, and fully aligned with PPB expectations, minimizing the risk of delays or rejections.
Regulated by the Pharmacy and Poisons Board (PPB)
ICH CTD-format submissions required
Kenya's PPB requires full compliance with the ICH CTD five-module structure. MedWisdom prepares each module with precision and scientific rigor, tailored to local PPB guidelines.
Country-specific content including the PPB application form, product monograph, approved labelling, package insert, summary of product characteristics (SmPC), and all administrative correspondence. This module's content varies according to Kenya's local regulatory requirements and must be tailored precisely for PPB submissions.
Comprehensive overviews of the quality, non-clinical, and clinical data presented in Modules 3–5. Includes the Quality Overall Summary (QOS), non-clinical overview, non-clinical written and tabulated summaries, clinical overview, and clinical written and tabulated summaries. This is a critical decision-making aid for PPB reviewers.
Full documentation of drug substance and drug product quality, including manufacturing processes, specifications, analytical procedures, validation studies, container-closure systems, stability data, and GMP compliance evidence. Accurate CMC data is foundational to a successful Kenya PPB approval.
Toxicology, pharmacology, and pharmacokinetic data from non-clinical (animal) studies. Includes primary pharmacodynamics, safety pharmacology, toxicokinetics, single and repeat-dose toxicity, genotoxicity, reproductive/developmental toxicity, and carcinogenicity studies as applicable.
Comprehensive clinical evidence including Phase I–III study reports, bioequivalence data (for generics), population PK analyses, individual patient data, and post-marketing experience. PPB evaluates this module to confirm safety and efficacy in the intended patient population in Kenya.
From initial strategy to post-approval compliance, MedWisdom delivers complete regulatory lifecycle support for health products in Kenya.
End-to-end compilation and writing of all five CTD modules for Kenya PPB marketing authorization applications - covering innovator medicines, generics, biologics, and complementary health products.
Expert review of existing CTD documentation against Kenya PPB expectations. We identify technical deficiencies, scientific gaps, and documentation inconsistencies before submission to reduce rejection risk.
Step-by-step regulatory guidance for medical device licensing with Kenya's PPB - covering Class A through Class D devices, conformity assessment, technical dossier preparation, and registration maintenance.
Preparation and submission of cosmetic product notifications and registrations to the PPB, including safety assessments, ingredient compliance screening, and labelling review against Kenyan standards.
Compilation and submission of CTA packages to the PPB and relevant ethics committees, including Investigational Medicinal Product Dossiers (IMPD), study protocols, and regulatory follow-up support.
Establishment of a local pharmacovigilance system, Individual Case Safety Report (ICSR) submissions, Periodic Safety Update Reports (PSUR), and Risk Management Plan (RMP) development for Kenya PPB compliance.
GMP site readiness assessments, internal QMS audits, corrective and preventive action (CAPA) implementation, and regulatory inspection preparedness aligned with Kenya PPB GMP requirements.
Review and optimization of product labels, package inserts, patient information leaflets (PIL), and outer packaging to meet all Kenya PPB labelling requirements, including mandatory local language considerations.
Management of type I and type II variations, renewals, amendments, and post-approval changes for Kenya PPB-registered products, ensuring continuous compliance throughout the product lifecycle.
Development of comprehensive safety and efficacy data packages, benefit-risk assessments, and gap analyses to support PPB marketing authorization dossiers for complex or innovative products.
End-to-end support for Kenya PPB import and export authorizations, batch release documentation, and customs compliance for regulated pharmaceutical and medical device products.
Assistance with pharmacy establishment licensing, wholesaler and distributor permits, and compliance with Kenya PPB facility and personnel requirements for regulated entities operating in Kenya.
Pharmacy & Poisons Board - Kenya's National Regulatory Authority for Health Products
A structured, transparent engagement model ensures your Kenya PPB submission is accurate, complete, and submitted on time.
We assess your existing data against Kenya PPB CTD requirements and identify documentation gaps.
Development of a customized regulatory strategy, timeline, and responsibility matrix for your submission.
Expert preparation of all five CTD modules, including scientific summaries, CMC data, and clinical reports.
Internal QC review by senior regulatory scientists to ensure accuracy, consistency, and compliance.
Formal dossier submission to Kenya PPB with ongoing query management and response support.
Lifecycle management including variations, renewals, and pharmacovigilance reporting to PPB.
Partner with MedWisdom Lifescience for expert, reliable, and fully compliant CTD dossier preparation and Kenya PPB registration support - from initial strategy to long-term market success.