Analytical Method Validation Services – India

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

We support pharmaceutical manufacturers across India with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO queries for manufacturing licenses, product approvals, and export registrations.

Our Core Expertise – India Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Central Drugs Standard Control Organization (CDSCO) and Drugs Controller General of India (DCGI).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) aligned with CDSCO expectations
• Accuracy, precision, linearity, robustness, and specificity
• IP / USP / BP / EP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation as per Schedule M, IP, and ICH requirements

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by CDSCO
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – India

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

Regulatory Compliance – India

All Analytical Method Validation activities are conducted in accordance with:

• CDSCO / DCGI Guidelines
• Drugs & Cosmetics Act, 1940 and Rules, 1945
• Schedule M and Schedule Y (where applicable)
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• Indian Pharmacopoeia (IP)
• WHO-GMP principles adopted by CDSCO

Post-Submission Regulatory Support – India

VALIDEX provides complete CDSCO / DCGI query management, including:

✅ Responses to CDSCO / DCGI deficiency letters
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during regulatory inspections and audits

Why Choose VALIDEX for India?

✔ Strong understanding of Indian regulatory expectations
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – India

• Analytical Method Validation Protocols (India-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• CTD / Non-CTD summaries for CDSCO submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – India

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharmaceutical units
• Regulatory and dossier consulting firms

National & Export Support – India

VALIDEX supports Analytical Method Validation for:

• Indian domestic approvals (CDSCO / DCGI)
• Manufacturing licenses and product permissions
• Export dossiers prepared in India
• WHO-tender and international market submissions

Partner with VALIDEX – India

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