Global Analytical Method Validation Services

VALIDEX

Global Analytical Method Validation Services

Ensuring Accuracy. Compliance. Regulatory Confidence.

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.
We support pharmaceutical manufacturers worldwide with ICH-compliant validation, regulatory documentation, and post-submission handling of MOH / FDA queries.

Our Core Expertise

We offer comprehensive preparation, review, and regulatory support for Analytical Method Validation covering:

✅ Assay Method Validation

• Potency and content determination

• ICH Q2 (R1 / R2) compliant protocols

• Accuracy, precision, linearity, robustness & specificity

✅ Impurities Method Validation

• Related substances & degradation products

• Identification & quantification of impurities

• Stability-indicating method validation

✅ Dissolution Method Validation

• Immediate & modified release products

• Discriminatory dissolution method development

• Media selection & sink condition assessment

✅ Residual Solvents Method Validation

• GC method validation as per ICH Q3C

• Class I, II, and III solvents

• Limits, system suitability & quantitation

Products Covered

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms

• ✅ Injectable formulations

• ✅ Semi-solids & liquids

• ✅ Modified & controlled release products

Regulatory Compliance

All validation activities are performed in line with:

• ICH Q2 (R1 / R2)

• US FDA Guidelines

• EMA / EU Requirements

• WHO & Global MOH Guidelines

• Pharmacopoeias (USP, EP, BP, IP)

Post-Submission Regulatory Support

VALIDEX provides complete regulatory query management, including:

• ✅ MOH / FDA deficiency response preparation

• ✅ Scientific justification & data gap analysis

• ✅ Revised validation reports & comparative data

• ✅ Technical responses for regulatory inspections

Why Choose VALIDEX?

✔ Scientific & regulatory expertise
✔ Global regulatory exposure
✔ Audit-ready documentation
✔ Fast turnaround timelines
✔ Confidentiality & data integrity
✔ One-point solution under Zoesoe Exports Pvt Ltd

Our Deliverables

• Analytical Method Validation Protocols

• Validation Reports (Assay, Impurities, Dissolution, Residual Solvents)

• Summary reports for CTD submissions

• Regulatory response packages

• Method transfer & verification support

Industries We Serve

• Pharmaceutical manufacturers

• Generic drug companies

• Contract manufacturing organizations (CMOs)

• Export-oriented pharma companies

• Regulatory dossier consultants

Global Reach

VALIDEX supports Analytical Method Validation projects for:

• 🇺🇸 USA

• 🇪🇺 Europe

• 🇨🇦 Canada

• 🌏 ASEAN

• 🌍 ROW markets

Partner with VALIDEX

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

“Analytical Validation That Meets Global Regulatory Standards.”

Excellence in AMV Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Analytical Method Validation Services (Global)

1. What is Analytical Method Validation?

Analytical Method Validation is the documented process that confirms an analytical method is suitable for its intended purpose. It ensures accuracy, precision, specificity, linearity, robustness, and reliability of analytical testing for pharmaceutical products in compliance with global regulatory guidelines.

2. Which regulatory guidelines does VALIDEX follow for method validation?

VALIDEX performs Analytical Method Validation in compliance with ICH Q2 (R1 / R2) and aligns documentation with requirements of US FDA, EMA, WHO, CDSCO, MHRA, Health Canada, and other global Medicines Authorities (MOH).

3. Which types of analytical methods does VALIDEX validate?

We validate analytical methods for:

• Assay

• Related substances / impurities

• Dissolution

• Residual solvents

• Content uniformity (where applicable)

Applicable to both APIs and finished pharmaceutical products.

4. Does VALIDEX provide method validation for both APIs and finished products?

Yes. VALIDEX provides complete Analytical Method Validation services for:

• Active Pharmaceutical Ingredients (APIs)

• Oral solid dosage forms

• Injectables

• Semi-solid formulations

• Liquid and modified-release products

5. Are VALIDEX validation reports suitable for global regulatory submissions?

Yes. All validation protocols and reports are prepared in a globally acceptable format, making them suitable for submissions to US FDA, EMA, WHO PQ, CDSCO, TGA, and ROW authorities.

6. Does VALIDEX support post-submission regulatory queries?

Yes. VALIDEX provides end-to-end post-submission support, including responses to MOH / FDA deficiency letters, scientific justifications, comparative data preparation, and revised validation documentation.

7. Can VALIDEX help with validation of compendial and non-compendial methods?

Yes. VALIDEX supports validation of both:

• Compendial methods (USP, EP, BP, IP)

• In-house / non-compendial methods, including method optimization and robustness studies.

8. Does VALIDEX provide stability-indicating method validation?

Yes. We specialize in stability-indicating analytical method validation, including forced degradation studies, impurity profiling, and method specificity demonstrations.

9. Can VALIDEX assist with method transfer and verification?

Yes. We provide analytical method transfer protocols, verification studies, and comparative data to support technology transfer between laboratories or manufacturing sites.

10. What documentation does VALIDEX deliver?

Our deliverables include:

• Validation protocols

• Validation reports (Assay, Impurities, Dissolution, Residual Solvents)

• Summary reports for CTD / eCTD submissions

• Regulatory query response packages

11. How does VALIDEX ensure data integrity and confidentiality?

VALIDEX follows strict data integrity practices aligned with ALCOA+ principles and maintains complete confidentiality through controlled documentation systems and secure data handling procedures.

12. How long does Analytical Method Validation take?

Timelines depend on method complexity and scope, but VALIDEX is known for fast, reliable turnaround times without compromising regulatory compliance or data quality.

13. Which countries does VALIDEX support globally?

VALIDEX supports Analytical Method Validation projects for clients in:

• USA

• Europe

• Canada

• ASEAN

• LATAM

• Middle East

• ROW markets

14. Why choose VALIDEX for global Analytical Method Validation?

VALIDEX offers:

• Global regulatory expertise

• ICH-compliant, audit-ready documentation

• Comprehensive pre- and post-submission support

• Scientific excellence backed by Zoesoe Exports Pvt Ltd

15. How can we start an Analytical Method Validation project with VALIDEX?

You can contact VALIDEX by email or through our website to share your product and regulatory requirements. Our scientific team will review your scope and propose a compliant validation strategy.