Analytical Method Validation Services – United States

Ensuring Accuracy. Compliance. Regulatory Confidence for U.S. FDA Submissions

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 United States FDA regulatory requirements.

We support pharmaceutical manufacturers, ANDA/NDA applicants, API manufacturers, CMOs, and global exporters targeting the U.S. market with FDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of U.S. FDA queries for IND, NDA, ANDA, DMF, BLA, and export dossiers.

Our Core Expertise – United States Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the U.S. Food and Drug Administration (FDA), including CDER and CBER, in line with 21 CFR and ICH guidelines.

✅ Assay Method Validation

• Potency, content, and strength determination
• Validation as per ICH Q2 (R1 / R2) accepted by U.S. FDA
• Accuracy, precision (repeatability & intermediate precision), linearity, range, robustness, and specificity
• USP / FDA / Ph. Eur. / IP 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 FDA & ICH expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D (including elemental impurities)

✅ Dissolution Method Validation

• Immediate-release, delayed-release, and modified-release products
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness studies
• Compliance with USP <711>, FDA dissolution guidance, and ANDA requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C and USP <467>
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, and LOQ/LOD evaluation

Products Covered – United States

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and complex formulations
✅ Combination products (where applicable)

Regulatory Compliance – United States

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• U.S. FDA Guidance for Industry – Analytical Procedures & Validation
• 21 CFR Parts 210 & 211 (cGMP)
• 21 CFR Part 314 (NDA / ANDA)
• USP–NF General Chapters
• FDA Data Integrity & ALCOA+ principles
• WHO Technical Report Series (TRS) (where applicable)

Post-Submission Regulatory Support – United States

VALIDEX provides complete U.S. FDA query and lifecycle management, including:

✅ Responses to FDA deficiency letters, IRs, and CRLs
✅ Scientific justification for validation strategies
✅ Data gap assessment and remediation support
✅ Revised validation protocols and reports
✅ Technical support during FDA inspections, audits, and pre-approval inspections (PAI)

Why Choose VALIDEX for the United States?

✔ Deep understanding of U.S. FDA expectations & inspection trends
✔ ICH-aligned, FDA-focused documentation
✔ Inspection-ready and audit-defensible validation reports
✔ Experience with ANDA, NDA, DMF, and export filings
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – United States

• FDA-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD Module 3 documentation (2.3 & 3.2.S / 3.2.P)
• ANDA / NDA / DMF validation summaries
• FDA query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in the United States

• Pharmaceutical manufacturing companies
• API manufacturers & DMF holders
• Generic drug companies (ANDA applicants)
• Innovator companies (NDA / IND sponsors)
• Contract Manufacturing Organizations (CMOs)
• Regulatory & dossier consulting firms

National & Global Export Support – United States

VALIDEX supports Analytical Method Validation for:

• U.S. FDA domestic submissions
• ANDA / NDA / IND / DMF filings
• Export dossiers prepared for FDA-regulated global markets
• Method validation bridging for US–EU–WHO markets

Partner with VALIDEX – United States

Achieve FDA-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for the United States.