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🇨🇿 Analytical Method Validation Services – Czech Republic

Zajištění Přesnosti, Souladu a Regulační Důvěry pro Podání na SÚKL (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to SÚKL)

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 the Czech Republic's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across the Czech Republic with compliance aligned with the State Institute for Drug Control (Státní ústav pro kontrolu léčiv - SÚKL), ICH-aligned documentation, and post-submission handling of SÚKL queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇨🇿 Our Core Expertise – Czech Republic Focus

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

• ✅ Assay Method Validation (Validace Metody Stanovení Obsahu)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validace Metody Stanovení Nečistot)

  • 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 (Validace Metody Stanovení Rychlosti Uvolňování)

  • 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 (Validace Metody Stanovení Reziduálních Rozpouštědel)

  • 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 – Czech Republic

• ✅ 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 – Czech Republic

All Analytical Method Validation activities are conducted in accordance with:

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

• SÚKL (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 (Czech Republic)

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

• ✅ Response to SÚKL deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇨🇿 Why Choose VALIDEX for the Czech Republic?

• ✔ Strong understanding of the SÚKL'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 – Czech Republic

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for SÚKL submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇨🇿 Industries We Serve in the Czech Republic

• 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:

• Czech Republic domestic approvals (Market Authorization from SÚKL).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇨🇿 Partner with VALIDEX – Czech Republic

Achieve SÚKL-ready analytical validation with confidence.

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

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