Analytical Method Validation Services – Baddi (India)

Ensuring Accuracy. Compliance. Regulatory Confidence for Baddi-Based Pharmaceutical Manufacturing Units

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 formulation manufacturers, CMOs, and export-oriented units located in Baddi–Nalagarh–Barotiwala (BNB) industrial belt with CDSCO-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of DCGI / CDSCO and State Drugs Control Administration queries for manufacturing licenses, product approvals, and export registrations.

Our Core Expertise – Baddi Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CDSCO, DCGI, Himachal Pradesh Drugs Control Administration, and the Indian Pharmacopoeia (IP).

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation impurity profiling
• 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 & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, 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 – Baddi

✅ Oral solid dosage forms (tablets, capsules, sachets)
✅ Liquid oral formulations (syrups, suspensions)
✅ Semi-solid dosage forms (ointments, creams, gels)
✅ Injectable formulations (where applicable)
✅ Modified-release & controlled-release products

Regulatory Compliance – Baddi (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 – Baddi

VALIDEX provides complete regulatory query management, including:

✅ Responses to CDSCO / DCGI & HP Drugs Control 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 Baddi?

✔ Deep understanding of Baddi pharma formulation cluster expectations
✔ ICH-aligned, CDSCO-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines for high-volume formulation units
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Baddi

• 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 Baddi

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

Domestic & Global Export Support – Baddi

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Baddi

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