Analytical Method Validation Services – Surat (India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Surat-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, formulation units, CMOs, and export-oriented pharmaceutical companies located in Surat, Hazira, Sachin GIDC, and surrounding industrial zones 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 – Surat 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 – Surat

✅ 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 – Surat (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 – Surat

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 Surat?

✔ Strong understanding of Surat’s API- and formulation-driven pharma ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for domestic & export-oriented units
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Surat

• 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 Surat

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

Domestic & Global Export Support – Surat

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Surat

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