Product Registration & Market Authorization
Preparation and submission of dossiers for medicines, medical devices, supplements, cosmetics and herbal products.
Services
Three disciplines, delivered as one engagement.
Regulatory Affairs secures market authorization. Quality Assurance demonstrates compliance through inspection-ready systems. Intellectual Property protects the brand you invest in. Managing these functions separately is where gaps, delays, and risk emerge.
01 — Regulatory Affairs
From pathway mapping to sustained authorization
GMP Application Support
Manufacturing site gap assessments, GMP application preparation, PPB inspection coordination, and regulatory follow-up through certification.
Regulatory Strategy
Defining pathways, timelines, and risk mitigation plans for compliant market entry.
Lifecycle Management
Management of variations, retentions, and renewals to maintain compliance and uninterrupted market authorization.
Regulatory Intelligence & Compliance Monitoring
Monitoring and communicating new guidelines, requirements, and regulatory changes.
Local Technical Representation (LTR)
Acting as the designated representative for foreign pharma entrants in Kenya.
Laboratory Analysis Support
Coordination of testing and analysis to meet regulatory and quality requirements.
Advertisement & Promotion Oversight
Review and compliance guidance for advertising, promotional materials, and product communications.
Training & Competency Programs
Training programs covering regulatory requirements, dossier preparation, GxP compliance, and inspection readiness.
02 — Quality Assurance
Systems that hold up when an inspector asks for evidence
Inspectors evaluate systems, not individuals. Compliance is demonstrated through consistent operational discipline, not temporary preparation.
GSDP Compliance Checks
Foundational audits to ensure distribution practices meet regulatory standards — storage conditions, temperature monitoring, segregation, transport validation and access control.
SOP Development
PPB-aligned procedures that standardize operations, support compliance, and reflect actual practice.
Inspection Readiness Audits
Pre-inspection audits that identify compliance gaps, support CAPA implementation, and prepare staff for regulatory and partner inspections.
Recall Readiness & Traceability
Systems and mock exercises that enable rapid product recalls through traceable batch records and controlled distribution logs.
Supplier & Vendor Audits
Qualification and monitoring of suppliers and distributors to secure the supply chain — questionnaires, audit reports, certificates, and risk-based evaluation.
Common non-conformities we close
- Missing calibration records
- Poor documentation control
- Incomplete temperature logs
- Unqualified suppliers
- Inadequate CAPA management
03 — Intellectual Property
Protect the brand before the dossier is filed
Trademark Search & Clearance
Trademark searches to assess the availability of proposed brand names and logos before market entry.
Regulatory Name Alignment
Alignment of proposed product names with regulatory requirements while preserving brand identity.
Filing Coordination with KIPI
Managing submissions and correspondence with the Kenya Industrial Property Institute for trademarks.
IP Risk Mitigation for Market Entry
Identification and mitigation of intellectual property risks that could delay market entry.
How we work
Our six-step compliance pathway
Each step has defined deliverables and a clear owner. You always know what has been completed, what is with PPB, and what happens next.
Regulatory pathway mapping
We define the correct PPB pathway, dossier type, requirements, and compliance obligations — confirming product classification early to avoid dossier rejection.
Dossier preparation
We review your dossier for completeness and alignment with PPB assessor expectations, module by module, against our CTD quality assurance checklist.
PPB submission & query management
We submit through the Scientific Office via PRIMS, manage communication, and respond to PPB queries with structured, assessor-aligned responses.
Quality system & supply chain management
We strengthen your QMS, GSDP practices, warehousing controls, and supplier qualification so the operation matches the documentation.
IP clearance & brand protection
We conduct trademark searches, naming checks, and coordinate filings with KIPI before the name is locked into artwork and labelling.
Post-approval compliance
We support ongoing compliance through variations, renewals, retentions, and regulatory intelligence updates throughout the product lifecycle.