Analytical Method Validation Services – Singapore

Ensuring Accuracy. Compliance. Regulatory Confidence for Singapore 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 Singapore regulatory requirements.

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

Our Core Expertise – Singapore Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Health Sciences Authority (HSA) under the Therapeutic Products Branch (TPB), Ministry of Health, Singapore.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by HSA Singapore
• 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 HSA & ICH expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial 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 HSA product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Singapore

✅ 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 – Singapore

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• HSA Guidelines on Therapeutic Products Registration
• Health Products Act (HPA) & Health Products (Therapeutic Products) Regulations
• ASEAN Common Technical Dossier (ACTD / ACTR)
• WHO-GMP Guidelines (recognized by HSA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Singapore

VALIDEX provides complete HSA query management, including:

✅ Responses to HSA screening and evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during HSA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Singapore?

✔ Strong understanding of HSA & ASEAN regulatory expectations
✔ ICH-aligned, ACTD-compliant documentation
✔ 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 – Singapore

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

Industries We Serve in Singapore

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and innovative formulation companies
• Contract Manufacturing Organizations (CMOs)
• Marketing Authorization Holders (MAHs)
• Importers, distributors, and regulatory consultants

National & Export Support – Singapore

VALIDEX supports Analytical Method Validation for:

• Singapore therapeutic product registration (HSA)
• Manufacturing and import license applications
• Export dossiers prepared for HSA-regulated and ASEAN markets

Partner with VALIDEX – Singapore

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