Analytical Method Validation Services – Kenya

Ensuring Accuracy. Compliance. Regulatory Confidence for Kenya Regulatory Submissions

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products, fully compliant with Kenyan regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Kenya with PPB-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Pharmacy and Poisons Board (PPB) queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Kenya Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Pharmacy and Poisons Board (PPB) under the Ministry of Health, Republic of Kenya.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by PPB Kenya
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with PPB & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with PPB product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by PPB Kenya
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Kenya

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Kenya

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• PPB Registration Guidelines & Technical Requirements
• Pharmacy and Poisons Act (Cap. 244), Laws of Kenya
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by PPB)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Kenya

VALIDEX provides complete PPB query management, including:

✅ Responses to PPB deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during PPB dossier reviews, inspections, and audits

Why Choose VALIDEX for Kenya?

✔ Strong understanding of PPB regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Kenya
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Kenya

• Analytical Method Validation Protocols (PPB-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for PPB submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Kenya

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Kenya

VALIDEX supports Analytical Method Validation for:

• Kenya domestic product registration (PPB)
• Manufacturing and import license applications
• Export dossiers prepared for PPB-regulated and WHO-referenced markets

Partner with VALIDEX – Kenya

Achieve PPB-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Kenya.