Analytical Method Validation Services – Nigeria

Ensuring Accuracy. Compliance. Regulatory Confidence for Nigeria 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 Nigerian regulatory requirements.

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

Our Core Expertise – Nigeria Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by NAFDAC under the Federal Ministry of Health, Federal Republic of Nigeria.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Nigeria

✅ 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 – Nigeria

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• NAFDAC Drug Registration Guidelines & Laboratory Requirements
• Food and Drugs Act & NAFDAC Act (Cap N1 LFN)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by NAFDAC)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Nigeria

VALIDEX provides complete NAFDAC query management, including:

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

Why Choose VALIDEX for Nigeria?

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

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

Industries We Serve in Nigeria

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

National & Export Support – Nigeria

VALIDEX supports Analytical Method Validation for:

• Nigeria domestic product registration (NAFDAC)
• Manufacturing and import permit applications
• Export dossiers prepared for NAFDAC-regulated and WHO-referenced markets

Partner with VALIDEX – Nigeria

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