🇸🇮 Analytical Method Validation Services – Slovenia

Zagotavljanje Natančnosti, Skladnosti in Regulativnega Zaupanja za Vloge pri JAZMP (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to JAZMP)

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 Slovenia's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Slovenia with compliance aligned with the Agency for Medicinal Products and Medical Devices (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke - JAZMP), ICH-aligned documentation, and post-submission handling of JAZMP queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇸🇮 Our Core Expertise – Slovenia Focus

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

• ✅ Assay Method Validation (Validacija Metode za Določanje Vsebnosti)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validacija Metode za Določanje Nečistoč)

  • 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 (Validacija Metode za Določanje Sprostitev)

  • 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 (Validacija Metode za Ostanke Topil)

  • 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 – Slovenia

• ✅ 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 – Slovenia

All Analytical Method Validation activities are conducted in accordance with:

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

• JAZMP Regulations and Slovenian 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 (Slovenia)

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

• ✅ Response to JAZMP deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇸🇮 Why Choose VALIDEX for Slovenia?

• ✔ Strong understanding of the JAZMP's regulatory interpretation and strict adherence to EU/EMA standards, leveraging Slovenia's role in the regional pharmaceutical industry.

• ✔ 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 – Slovenia

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for JAZMP submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇸🇮 Industries We Serve in Slovenia

• Pharmaceutical manufacturing companies (especially those involved in generic production and export).

• 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:

• Slovenia domestic approvals (Market Authorization from JAZMP).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇸🇮 Partner with VALIDEX – Slovenia

Achieve JAZMP-ready analytical validation with confidence.

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