🇮🇱 Analytical Method Validation Services – Israel

Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the MoH

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 in full compliance with Israel's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Israel with compliance aligned with the Ministry of Health (MoH), particularly the Pharmaceutical Division, ICH-aligned documentation, and post-submission handling of MoH queries for drug registration, licensing, and import/export requirements.

🇮🇱 Our Core Expertise – Israel Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Israeli Ministry of Health, referencing ICH guidelines and recognized pharmacopoeial standards (mainly USP and EP).

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with MoH expectations.

  • Accuracy, precision, linearity, range, robustness, and specificity.

  • USP/EP/BP harmonized methods.

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

  • Stability-indicating method validation as per ICH Q3 and MoH guidelines.

• ✅ Dissolution Method Validation

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

  • Media selection, sink condition assessment, and method robustness.

  • Compliance with product registration requirements, submitted in CTD format.

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by the MoH).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇮🇱 Products Covered – Israel

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇮🇱 Regulatory Compliance – Israel

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) and other relevant ICH guidelines.

• MoH Pharmaceutical Division Guidelines and Israeli national regulations.

• United States Pharmacopeia (USP) and European Pharmacopoeia (EP) (primary references).

• Good Manufacturing Practices (GMP) adopted by the MoH.

🇮🇱 Post-Submission Regulatory Support (Israel)

VALIDEX provides complete regulatory query management, assisting with responses to MoH queries and technical review requirements, including:

• ✅ Response to MoH deficiency letters (often focusing on CMC data in Module 3).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during MoH inspections & audits.

🇮🇱 Why Choose VALIDEX for Israel?

• ✔ Strong understanding of the MoH's rigorous regulatory expectations and adherence to international (US/EU) standards.

• ✔ ICH-aligned documentation focused on Israeli national compliance norms.

• ✔ Inspection-ready and audit-compliant validation reports.

• ✔ Fast turnaround timelines.

• ✔ Strict confidentiality & data integrity.

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd.

🇮🇱 Our Deliverables – Israel

• Analytical Method Validation Protocols (MoH-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for MoH submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇮🇱 Industries We Serve in Israel

• Pharmaceutical manufacturing companies.

• API manufacturers and importers.

• Generic formulation companies.

• Contract Manufacturing Organizations (CMOs).

• Import and Distribution companies.

• Regulatory & dossier consulting firms.

🇮🇱 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Israel domestic approvals (Drug Registration from MoH).

• Manufacturing licenses & product permissions.

• Export dossiers globally.

🇮🇱 Partner with VALIDEX – Israel

Achieve MoH-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Israel.