Analytical Method Validation Services – Iran

Ensuring Accuracy. Compliance. Regulatory Confidence for Iran Regulatory 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 Iranian regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Iran with IFDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Iran Food and Drug Administration (IFDA) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Iran Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Iran Food and Drug Administration (IFDA), Ministry of Health and Medical Education (MOHME).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by IFDA Iran
• Accuracy, precision, linearity, robustness, and specificity
• Harmonized analytical methods as per USP / BP / EP / IP

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with IFDA and ICH expectations

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with IFDA product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by IFDA Iran
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Iran

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

Regulatory Compliance – Iran

All Analytical Method Validation activities are conducted in accordance with:

• Iran Food and Drug Administration (IFDA) guidelines
• Ministry of Health and Medical Education (MOHME) regulations
• National Drug Registration Requirements of Iran
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by IFDA
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Iran

VALIDEX provides complete IFDA query management, including:

✅ Responses to IFDA deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during IFDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Iran?

✔ Strong understanding of IFDA regulatory expectations
✔ ICH-aligned, Iran-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Iran registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Iran

• Analytical Method Validation Protocols (Iran-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for IFDA submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Iran

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharmaceutical units
• Regulatory and dossier consulting firms

National & Export Support – Iran

VALIDEX supports Analytical Method Validation for:

• Iran domestic product registration (IFDA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Iran
• Government tenders and institutional supply registrations

Partner with VALIDEX – Iran

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