Analytical Method Validation Services – The Gambia

Ensuring Accuracy. Compliance. Regulatory Confidence for Gambia 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 Gambian regulatory requirements.

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

Our Core Expertise – Gambia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Medicines Control Agency (MCA) under the Ministry of Health, Republic of The Gambia.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – The Gambia

✅ 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 – The Gambia

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MCA Registration Guidelines & Technical Requirements
• Medicines and Related Products Act, 2014 (The Gambia)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by MCA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – The Gambia

VALIDEX provides complete MCA query management, including:

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

Why Choose VALIDEX for The Gambia?

✔ Strong understanding of MCA regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in The Gambia
✔ 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 – The Gambia

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

Industries We Serve in The Gambia

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

National & Export Support – The Gambia

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – The Gambia

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