🇨🇳 Analytical Method Validation Services – Asia

VALIDEX – Asia

Analytical Method Validation Services for Asian Regulatory Markets

Accuracy. Compliance. Regulatory Confidence.

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 across Asian regulatory markets.

We support pharmaceutical manufacturers supplying to ASEAN, South Asia, Middle East-Asia corridor, and other Asian MOH jurisdictions with ICH-compliant validation, regulatory documentation, and post-submission query handling.

Our Core Expertise

VALIDEX provides complete preparation, review, and regulatory support for Analytical Method Validation including:

✅ Assay Method Validation

• Potency and content determination
• ICH Q2 compliant validation protocols
• Evaluation of:

• Accuracy

• Precision

• Linearity

• Robustness

• Specificity

✅ Impurities Method Validation

• Related substances analysis
• Identification & quantification of impurities
• Stability-indicating method validation
• Forced degradation studies support

✅ Dissolution Method Validation

• Immediate release dosage forms
• Modified & controlled release products
• Discriminatory dissolution method development
• Media selection & sink condition evaluation

✅ Residual Solvents Method Validation

• GC method validation as per ICH Q3C

Coverage includes:

• Class I solvents
• Class II solvents
• Class III solvents

Validation includes:

• Limit testing
• System suitability
• Quantitation and detection limits

Products Covered

VALIDEX supports validation for a wide range of pharmaceutical products:

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (Tablets & Capsules)
✅ Injectable formulations
✅ Semi-solid formulations (creams, gels, ointments)
✅ Liquid formulations (oral & topical)
✅ Modified & controlled release products

Regulatory Compliance (Asia Focus)

All validation activities follow internationally accepted and Asian regulatory expectations:

• ICH Q2
• World Health Organization pharmaceutical guidelines
• Association of Southeast Asian Nations Common Technical Dossier (ACTD) requirements
• National MOH regulatory requirements across Asian countries
• Pharmacopoeial standards:

• United States Pharmacopeia

• European Pharmacopoeia

• British Pharmacopoeia

• Indian Pharmacopoeia

Post-Submission Regulatory Support

VALIDEX provides complete regulatory query management for Asian authorities, including:

✅ MOH deficiency response preparation
✅ Scientific justification and data gap analysis
✅ Updated validation reports and comparative data
✅ Technical responses for regulatory inspections
✅ Support for ACTD dossier queries

Why Choose VALIDEX?

✔ Strong scientific and regulatory expertise
✔ Experience with Asian regulatory submissions
✔ ACTD-ready validation documentation
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ One-point solution under Zoesoe Exports Pvt Ltd

Our Deliverables

• Analytical Method Validation Protocols
• Validation Reports (Assay, Impurities, Dissolution, Residual Solvents)
• Summary reports for ACTD dossier submissions
• Regulatory response documentation
• Method transfer & verification support

Industries We Serve

• Pharmaceutical manufacturers
• Generic drug companies
• Contract manufacturing organizations (CMOs)
• Export-oriented pharmaceutical companies
• Regulatory dossier consultants

Asia Market Coverage

VALIDEX supports Analytical Method Validation projects across major Asian pharmaceutical markets, including:

🇮🇳 India
🇹🇭 Thailand
🇻🇳 Vietnam
🇵🇭 Philippines
🇲🇾 Malaysia
🇮🇩 Indonesia
🇸🇬 Singapore
🇰🇷 South Korea
🇯🇵 Japan
🌏 ASEAN & other Asian MOH jurisdictions

Partner with VALIDEX

Achieve regulatory-ready analytical method validation for Asian markets with confidence.

From method validation to regulatory approval, VALIDEX is your trusted scientific partner for Asia-focused pharmaceutical submissions.