Analytical Method Validation Services – Jordan

Ensuring Accuracy. Compliance. Regulatory Confidence for Jordan 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 Jordanian regulatory requirements.

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

Our Core Expertise – Jordan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the Jordan Food and Drug Administration (JFDA), Hashemite Kingdom of Jordan.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by JFDA
• 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 JFDA 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 JFDA product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Jordan

✅ 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 – Jordan

All Analytical Method Validation activities are conducted in accordance with:

• Jordan Food and Drug Administration (JFDA) guidelines
• Jordan Drug and Pharmacy Law and related regulations
• JFDA pharmaceutical product registration requirements
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by JFDA
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Jordan

VALIDEX provides complete JFDA query management, including:

✅ Responses to JFDA 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 JFDA inspections, audits, and dossier evaluations

Why Choose VALIDEX for Jordan?

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

Our Deliverables – Jordan

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

Industries We Serve – Jordan

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

National & Export Support – Jordan

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Jordan

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