Analytical Method Validation Services – Nepal

Ensuring Accuracy. Compliance. Regulatory Confidence for Nepal 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 Nepalese regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Nepal with DDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Department of Drug Administration (DDA) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Nepal Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Department of Drug Administration (DDA), Ministry of Health and Population, Government of Nepal.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with DDA Nepal and ICH expectations

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by DDA Nepal
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Nepal

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

Regulatory Compliance – Nepal

All Analytical Method Validation activities are conducted in accordance with:

• Department of Drug Administration (DDA), Nepal guidelines
• Drug Act, 1978 (Nepal) and associated rules
• National Drug Registration Requirements of Nepal
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by DDA Nepal
• Recognized pharmacopoeias (IP, USP, BP, EP)

Post-Submission Regulatory Support – Nepal

VALIDEX provides complete DDA Nepal query management, including:

✅ Responses to DDA deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during DDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Nepal?

✔ Strong understanding of Nepal DDA regulatory expectations
✔ ICH-aligned, Nepal-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Nepal registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Nepal

• Analytical Method Validation Protocols (Nepal-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for DDA Nepal submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Nepal

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

National & Export Support – Nepal

VALIDEX supports Analytical Method Validation for:

• Nepal domestic product registration (DDA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Nepal
• Government tenders and institutional supply registrations

Partner with VALIDEX – Nepal

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