🇮🇪 Analytical Method Validation Services – Ireland

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

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 Ireland's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Ireland with compliance aligned with the Health Products Regulatory Authority (HPRA), ICH-aligned documentation, and post-submission handling of HPRA queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇮🇪 Our Core Expertise – Ireland Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the HPRA and the stringent standards of the European Union (EU). Ireland, as a key EU member state, strictly adheres to the European Pharmacopoeia (Ph. Eur.) and ICH guidelines, and is often involved as a Reference Member State (RMS) in EU procedures.

• ✅ Assay Method Validation (Bailíochtú Modhanna Measúnachta)

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with HPRA and EMA/EU expectations.

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

  • Ph. Eur./USP/BP harmonized methods.

• ✅ Impurities Method Validation (Bailíochtú Modhanna Neamhíonachtaí)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation (Bailíochtú Modhanna Díscaoilte)

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

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

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

• ✅ Residual Solvents Method Validation (Bailíochtú Modhanna Tuaslagóirí Iarmharacha)

  • Gas Chromatographic (GC) method validation.

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

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇮🇪 Products Covered – Ireland

• ✅ 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 – Ireland

All Analytical Method Validation activities are conducted in accordance with:

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

• HPRA (Health Products Regulatory Authority) Regulations and national pharmaceutical laws.

• European Pharmacopoeia (Ph. Eur.) and relevant EU Directives/Regulations.

• EU Good Manufacturing Practices (GMP).

• United States Pharmacopeia (USP) and British Pharmacopoeia (BP) (where applicable).

🇮🇪 Post-Submission Regulatory Support (Ireland)

VALIDEX provides complete regulatory query management, assisting with responses to HPRA (and potentially EMA for centralized procedures) queries and technical review requirements, including:

• ✅ Response to HPRA deficiency letters (often regarding CMC data in Module 3).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during HPRA/EU inspections & audits.

🇮🇪 Why Choose VALIDEX for Ireland?

• ✔ Strong understanding of the HPRA's regulatory interpretation and strict adherence to EU/EMA standards, particularly in its role as a key regulatory jurisdiction.

• ✔ ICH-aligned documentation focused on European 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 – Ireland

• Analytical Method Validation Protocols (EU/HPRA-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for HPRA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇮🇪 Industries We Serve in Ireland

• Pharmaceutical manufacturing companies (especially those involved in export and R&D).

• 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:

• Ireland domestic approvals (Market Authorization from HPRA).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇮🇪 Partner with VALIDEX – Ireland

Achieve HPRA-ready analytical validation with confidence.

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