Analytical Method Validation Services – Zambia

Ensuring Accuracy. Compliance. Regulatory Confidence for Zambia 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 Zambian regulatory requirements.

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

Our Core Expertise – Zambia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Zambia Medicines Regulatory Authority (ZAMRA) under the Ministry of Health, Republic of Zambia.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by ZAMRA Zambia
• 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 ZAMRA & 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 ZAMRA product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Zambia

✅ 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 – Zambia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ZAMRA Registration Guidelines & Technical Requirements
• Medicines and Allied Substances Act (Zambia)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by ZAMRA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Zambia

VALIDEX provides complete ZAMRA query management, including:

✅ Responses to ZAMRA 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 ZAMRA dossier reviews, inspections, and audits

Why Choose VALIDEX for Zambia?

✔ Strong understanding of ZAMRA regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Zambia
✔ 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 – Zambia

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

Industries We Serve in Zambia

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

National & Export Support – Zambia

VALIDEX supports Analytical Method Validation for:

• Zambia domestic product registration (ZAMRA)
• Manufacturing and import authorization applications
• Export dossiers prepared for ZAMRA-regulated and WHO-referenced markets

Partner with VALIDEX – Zambia

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