Analytical Method Validation Services – Taiwan

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

We support pharmaceutical manufacturers, API suppliers, importers, local agents, Marketing Authorization Holders (MAHs), CMOs, and export-oriented companies targeting Taiwan with Taiwan Food and Drug Administration (TFDA)–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of TFDA queries for drug registration, import approval, and lifecycle management.

Our Core Expertise – Taiwan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, aligned with ICH guidelines and international pharmacopoeias accepted in Taiwan.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) adopted by TFDA
• Accuracy, precision, linearity, range, robustness, and specificity
• USP / BP / Ph. Eur. / JP harmonized analytical methods with TFDA justification

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per TFDA technical review expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by TFDA
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ

Products Covered – Taiwan

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

Regulatory Compliance – Taiwan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Taiwan FDA (TFDA) Drug Registration Regulations
• ICH Q3A / Q3B / Q3C / Q3D
• PIC/S GMP (adopted by Taiwan)
• WHO-GMP / EU-GMP / US FDA GMP (accepted for imports)

Post-Submission Regulatory Support – Taiwan

VALIDEX provides complete TFDA regulatory query management, including:

✅ Responses to TFDA deficiency letters
✅ Scientific justification for analytical & validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during TFDA technical reviews & GMP inspections

Why Choose VALIDEX for Taiwan?

✔ Strong understanding of TFDA technical and GMP expectations
✔ ICH-aligned, Taiwan-specific documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting imported drugs, APIs & MAH dossiers
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Taiwan

• TFDA-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Taiwan CTD analytical summaries
• TFDA regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – Taiwan

• Pharmaceutical manufacturers exporting to Taiwan
• API manufacturers
• Importers & local agents
• Marketing Authorization Holders (MAHs)
• Contract Manufacturing Organizations (CMOs)
• Regulatory & dossier consulting firms

Import & Market Access Support – Taiwan

VALIDEX supports Analytical Method Validation for:

• TFDA drug registration (imported medicines)
• New registrations, renewals & variations
• Post-approval lifecycle management
• Export dossiers prepared for Taiwan from India, EU, US & ASEAN

Partner with VALIDEX – Taiwan

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