🇮🇹 Analytical Method Validation Services – Italy

Garanzia di Accuratezza, Conformità e Fiducia Regolatoria per le Sottomissioni all'AIFA (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to AIFA)

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 Italy's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Italy with compliance aligned with the Italian Medicines Agency (Agenzia Italiana del Farmaco - AIFA), ICH-aligned documentation, and post-submission handling of AIFA queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇮🇹 Our Core Expertise – Italy Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by AIFA and the stringent standards of the European Union (EU). Italy, as a major EU member state, strictly adheres to the European Pharmacopoeia (Ph. Eur.) and ICH guidelines.

• ✅ Assay Method Validation (Validazione del Metodo di Saggio)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validazione del Metodo per le Impurezze)

  • 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 (Validazione del Metodo di Dissoluzione)

  • 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 (Validazione del Metodo per Solventi Residui)

  • 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 – Italy

• ✅ 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 – Italy

All Analytical Method Validation activities are conducted in accordance with:

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

• AIFA (Italian Medicines Agency) Regulations and Italian 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 (Italy)

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

• ✅ Response to AIFA deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇮🇹 Why Choose VALIDEX for Italy?

• ✔ Strong understanding of AIFA's regulatory interpretation and strict adherence to EU/EMA standards, leveraging Italy's central role in European pharmaceutical manufacturing.

• ✔ 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 – Italy

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for AIFA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇮🇹 Industries We Serve in Italy

• 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:

• Italy domestic approvals (Market Authorization from AIFA).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇮🇹 Partner with VALIDEX – Italy

Achieve AIFA-ready analytical validation with confidence.

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