Analytical Method Validation Services – Philippines

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

We support pharmaceutical manufacturers, importers, and exporters targeting the Philippines with FDA Philippines-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of FDA Philippines (CDRR) queries for product registration, CPR approvals, manufacturing/import licenses, and export dossiers.

Our Core Expertise – Philippines Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Food and Drug Administration (FDA) Philippines, Center for Drug Regulation and Research (CDRR), under the Department of Health (DOH).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by FDA Philippines
• 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 FDA Philippines & ASEAN expectations
• Compliance with USP / BP impurity limits and ICH guidelines

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with FDA Philippines CPR and post-approval requirements

✅ Residual Solvents Method Validation

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

Products Covered – Philippines

✅ 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 – Philippines

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• FDA Philippines (CDRR) Guidelines & Circulars
• Republic Act No. 9711 (FDA Act of 2009)
• ASEAN Common Technical Dossier (ACTD / ACTR)
• WHO-GMP Guidelines
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Philippines

VALIDEX provides complete FDA Philippines / CDRR query management, including:

✅ Responses to FDA Philippines deficiency letters & evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during FDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for the Philippines?

✔ Strong understanding of FDA Philippines & 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 – Philippines

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

Industries We Serve in the Philippines

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

National & Export Support – Philippines

VALIDEX supports Analytical Method Validation for:

• Philippine domestic product registration (FDA CPR)
• Import license and marketing authorization support
• Export dossiers prepared for FDA Philippines & ASEAN markets

Partner with VALIDEX – Philippines

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