Analytical Method Validation Services – Namibia

Ensuring Accuracy. Compliance. Regulatory Confidence for Namibia 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 Namibian regulatory requirements.

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

Our Core Expertise – Namibia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Namibia Medicines Regulatory Council (NMRC) under the Ministry of Health and Social Services (MoHSS), Republic of Namibia.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Namibia

✅ 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 – Namibia

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Namibia

VALIDEX provides complete NMRC query management, including:

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

Why Choose VALIDEX for Namibia?

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

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

Industries We Serve in Namibia

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

National & Export Support – Namibia

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Namibia

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