Analytical Method Validation Services – Gurgaon (Gurugram, India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Gurgaon-Based Pharmaceutical & Regulatory Organizations

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 companies, Marketing Authorization Holders (MAHs), formulation manufacturers, CMOs, CROs, R&D centers, and regulatory consulting firms located in Gurgaon/Gurugram and across Haryana with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and Haryana Drugs Control Department queries for manufacturing licenses, product approvals, regulatory filings, and export registrations.

Our Core Expertise – Gurgaon Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Haryana State Drugs Control Department, 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 – Gurgaon

✅ 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 – Gurgaon (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 – Gurgaon

VALIDEX provides complete regulatory query management, including:

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

Why Choose VALIDEX in Gurgaon?

✔ Strong understanding of Gurgaon’s MAH-, regulatory-, and corporate-driven pharma ecosystem
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Ideal partner for MAHs, regulatory offices & dossier-driven organizations
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Gurgaon

• 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 Gurgaon

• Marketing Authorization Holders (MAHs)
• Pharmaceutical formulation companies
• API suppliers & sourcing offices
• Contract Manufacturing Organizations (CMOs)
• Contract Research Organizations (CROs)
• Regulatory & dossier consulting firms
• Export-oriented pharma companies

Domestic & Global Export Support – Gurgaon

VALIDEX supports Analytical Method Validation for:

• CDSCO / DCGI domestic approvals
• Haryana State manufacturing & wholesale licenses
• Export dossiers coordinated from Gurgaon for:
US FDA | EU | UK | WHO | LATAM | Africa | ASEAN | GCC

Partner with VALIDEX – Gurgaon

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