🇦🇹 Analytical Method Validation Services – Austria

Gewährleistung von Genauigkeit, Konformität und Regulatorischem Vertrauen für Einreichungen bei der BASG (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the BASG)

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 Austria's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Austria with compliance aligned with the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen - BASG), ICH-aligned documentation, and post-submission handling of BASG queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇦🇹 Our Core Expertise – Austria Focus

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

• ✅ Assay Method Validation (Validierung der Gehaltsbestimmungsmethode)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validierung der Verunreinigungsmethode)

  • 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 (Validierung der Auflösungsmethode)

  • 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 (Validierung der Methode für Restlösungsmittel)

  • 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 – Austria

• ✅ 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 – Austria

All Analytical Method Validation activities are conducted in accordance with:

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

• BASG (Federal Office for Safety in Health Care) Regulations and Austrian 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 (Austria)

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

• ✅ Response to BASG deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇦🇹 Why Choose VALIDEX for Austria?

• ✔ Strong understanding of the BASG's regulatory interpretation and strict adherence to EU/EMA standards, particularly its role within the German-speaking pharmaceutical landscape.

• ✔ 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 – Austria

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for BASG submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇦🇹 Industries We Serve in Austria

• 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:

• Austria domestic approvals (Market Authorization from BASG).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇦🇹 Partner with VALIDEX – Austria

Achieve BASG-ready analytical validation with confidence.

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