Analytical Method Validation Services – Vapi (India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Vapi-Based Pharmaceutical & API Manufacturers

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, bulk drug producers, formulation units, CMOs, and export-oriented pharmaceutical companies located in Vapi GIDC and surrounding industrial belts of Gujarat 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 – Vapi 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 & 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 – Vapi

✅ 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 – Vapi (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 – Vapi

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 Vapi?

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

Our Deliverables – Vapi

• 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 Vapi

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

Domestic & Global Export Support – Vapi

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Vapi

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