Analytical Method Validation Services – Pune (India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Pune-Based Pharmaceutical & Biopharmaceutical Companies

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, API producers, biopharmaceutical companies, CMOs, CROs, and export-oriented pharma units located in Pune, Pimpri-Chinchwad, Talegaon, Chakan, and Hinjewadi with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and Maharashtra FDA queries for manufacturing licenses, product approvals, and global export registrations.

Our Core Expertise – Pune Focus

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

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• 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, delayed-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and 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 – Pune

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, sachets)
✅ Liquid oral formulations (syrups, suspensions)
✅ Semi-solid dosage forms (ointments, creams, gels)
✅ Injectable formulations (sterile & non-sterile)
✅ Modified-release & controlled-release products
✅ Biopharmaceutical & R&D materials (where applicable)

Regulatory Compliance – Pune (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 – Pune

VALIDEX provides complete regulatory query management, including:

✅ Responses to CDSCO / DCGI & Maharashtra FDA deficiency letters
✅ Scientific justification for validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during GMP inspections, audits & biopharma facility reviews

Why Choose VALIDEX in Pune?

✔ Strong understanding of Pune’s pharma, biotech & R&D-driven ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Expertise supporting R&D, clinical, commercial & export projects
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Pune

• 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 Pune

• Pharmaceutical manufacturing companies
• API manufacturers
• Biopharmaceutical & biotech companies
• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)
• Export-oriented pharma units

Domestic & Global Export Support – Pune

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Pune

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