Analytical Method Validation Services – Malaysia

Ensuring Accuracy. Compliance. Regulatory Confidence for Malaysia 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 Malaysian regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Malaysia with NPRA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of National Pharmaceutical Regulatory Agency (NPRA) queries for product registration, import licensing, and export dossiers.

Our Core Expertise – Malaysia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH), Malaysia.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with NPRA 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 NPRA product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Malaysia

✅ 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 – Malaysia

All Analytical Method Validation activities are conducted in accordance with:

• National Pharmaceutical Regulatory Agency (NPRA) guidelines
• Control of Drugs and Cosmetics Regulations (CDCR) 1984
• Drug Registration Guidance Document (DRGD)
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP / PIC/S GMP principles adopted by Malaysia
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Malaysia

VALIDEX provides complete NPRA query management, including:

✅ Responses to NPRA 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 NPRA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Malaysia?

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

Our Deliverables – Malaysia

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

Industries We Serve – Malaysia

• 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 – Malaysia

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Malaysia

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