🇸🇰 Analytical Method Validation Services – Slovakia

Zabezpečenie Presnosti, Súladu a Regulačnej Dôvery pre Podania na ŠÚKL (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to ŠÚKL)

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 Slovakia's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Slovakia with compliance aligned with the State Institute for Drug Control (ŠÚKL), ICH-aligned documentation, and post-submission handling of ŠÚKL queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇸🇰 Our Core Expertise – Slovakia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by ŠÚKL (Slovakia's competent authority) and the stringent standards of the European Union (EU), referencing the European Pharmacopoeia (Ph. Eur.) and ICH guidelines.

• ✅ Assay Method Validation (Validácia Metódy Stanovenia Účinnosti)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validácia Metódy Stanovenia Nečistôt)

  • 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 (Validácia Metódy Skúšania Rozpúšťania)

  • 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 (Validácia Metódy Stanovenia Reziduálnych Rozpúšťadiel)

  • 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 – Slovakia

• ✅ 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 – Slovakia

All Analytical Method Validation activities are conducted in accordance with:

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

• ŠÚKL (State Institute for Drug Control) 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 (Slovakia)

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

• ✅ Response to ŠÚKL deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during ŠÚKL inspections & audits.

🇸🇰 Why Choose VALIDEX for Slovakia?

• ✔ Strong understanding of ŠÚKL's regulatory interpretation and strict adherence to EU/EMA standards.

• ✔ 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 – Slovakia

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for ŠÚKL submissions (typically in English/Slovak).

• Regulatory query response packages.

• Method transfer & verification documentation.

🇸🇰 Industries We Serve in Slovakia

• 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:

• Slovakia domestic approvals (Market Authorization from ŠÚKL).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇸🇰 Partner with VALIDEX – Slovakia

Achieve ŠÚKL-ready analytical validation with confidence.

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