Analytical Method Validation Services – Mumbai (India)
Ensuring Accuracy. Compliance. Regulatory Confidence for Mumbai-Based Pharmaceutical & Corporate Pharma Offices
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 companies, formulation units, CMOs, CROs, Marketing Authorization Holders (MAHs), corporate regulatory offices, and export-driven pharma organizations located in Mumbai, Navi Mumbai, Thane, and the Mumbai Metropolitan Region (MMR) 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, regulatory filings, and global export registrations.
Our Core Expertise – Mumbai 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 & finished formulations
• 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 – Mumbai
✅ 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
Regulatory Compliance – Mumbai (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 – Mumbai
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, regulatory audits & corporate reviews
Why Choose VALIDEX in Mumbai?
✔ Strong understanding of Mumbai’s corporate, regulatory & manufacturing pharma ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Ideal partner for corporate HO, MAHs & export-facing regulatory teams
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Mumbai
• 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 Mumbai
• Pharmaceutical manufacturing companies
• API manufacturers & suppliers
• Corporate head offices & MAHs
• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)
• Regulatory & dossier consulting firms
• Export-oriented pharma companies
Domestic & Global Export Support – Mumbai
VALIDEX supports Analytical Method Validation for:
• CDSCO / DCGI domestic approvals
• Maharashtra State manufacturing & wholesale licenses
• Export dossiers coordinated from Mumbai for:
US FDA | EU | UK | WHO | LATAM | Africa | ASEAN | GCC
Partner with VALIDEX – Mumbai
Achieve CDSCO-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Mumbai.