Analytical Method Validation Services – Ankleshwar (India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Ankleshwar-Based Pharmaceutical & API Units

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 API manufacturers, formulation units, CMOs, and export-oriented pharmaceutical companies located in Ankleshwar GIDC and Bharuch region with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and Gujarat FDCA queries for manufacturing licenses, product approvals, and global export registrations.

Our Core Expertise – Ankleshwar Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Gujarat FDCA, and the Indian Pharmacopoeia (IP).

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation impurity profiling
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per Schedule M & IP
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities)

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Ankleshwar

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

Regulatory Compliance – Ankleshwar (India)

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Ankleshwar

VALIDEX provides complete regulatory query management, including:

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

Why Choose VALIDEX in Ankleshwar?

✔ Deep understanding of Ankleshwar GIDC API & bulk drug regulatory expectations
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for API & export-driven units
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Ankleshwar

• India-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summaries for CDSCO submissions
• Regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve in Ankleshwar

• API & bulk drug manufacturers
• Pharmaceutical formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharma units
• Regulatory & dossier consulting firms

Domestic & Global Export Support – Ankleshwar

VALIDEX supports Analytical Method Validation for:

• CDSCO / DCGI domestic approvals
• Gujarat FDCA manufacturing licenses
• Export dossiers prepared in Ankleshwar for:
US FDA | EU | UK | WHO | LATAM | Africa | ASEAN | GCC

Partner with VALIDEX – Ankleshwar

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