Analytical Method Validation Services – Sri Lanka

Ensuring Accuracy. Compliance. Regulatory Confidence for Sri Lanka 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 Sri Lanka regulatory requirements.

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

Our Core Expertise – Sri Lanka Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the National Medicines Regulatory Authority (NMRA) under the Ministry of Health, Sri Lanka.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Sri Lanka

✅ 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 – Sri Lanka

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• NMRA Guidelines & Registration Requirements
• National Medicines Regulatory Authority Act No. 5 of 2015
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (as adopted by NMRA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Sri Lanka

VALIDEX provides complete NMRA query management, including:

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

Why Choose VALIDEX for Sri Lanka?

✔ Strong understanding of NMRA regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Sri Lanka
✔ 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 – Sri Lanka

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

Industries We Serve in Sri Lanka

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

National & Export Support – Sri Lanka

VALIDEX supports Analytical Method Validation for:

• Sri Lanka domestic product registration (NMRA)
• Manufacturing and import license applications
• Export dossiers prepared for NMRA-regulated and WHO-referenced markets

Partner with VALIDEX – Sri Lanka

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