🇭🇺 Analytical Method Validation Services – Hungary

Biztosítjuk a Pontosságot, Megfelelést, Szabályozási Bizalmat a Magyarországi Benyújtásokhoz (Ensuring Accuracy, Compliance, Regulatory Confidence for Hungary Submissions)

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 Hungary's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Hungary with compliance aligned with the National Institute of Pharmacy and Nutrition (OGYÉI), ICH-aligned documentation, and post-submission handling of OGYÉI queries for medicinal product authorization, manufacturing licenses, and EU/EEA requirements.

🇭🇺 Our Core Expertise – Hungary Focus

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

• ✅ Assay Method Validation (Hatóanyag-tartalom Meghatározásának Validálása)

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with OGYÉI and EU requirements

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

  • Ph. Eur./USP/BP harmonized methods

• ✅ Impurities Method Validation (Szennyezőanyag-vizsgálati Módszer Validálása)

  • 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 (Oldódási Vizsgálat Validálása)

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with product registration requirements, typically submitted in EU CTD format.

• ✅ Residual Solvents Method Validation (Maradék Oldószerek Vizsgálatának Validálása)

  • 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 – Hungary

• ✅ 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 – Hungary

All Analytical Method Validation activities are conducted in accordance with:

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

• OGYÉI (National Institute of Pharmacy and Nutrition) Regulations

• 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 (Hungary)

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

• ✅ Response to OGYÉI deficiency letters

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during OGYÉI inspections & audits

🇭🇺 Why Choose VALIDEX for Hungary?

• ✔ Strong understanding of OGYÉI'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 – Hungary

• Analytical Method Validation Protocols (EU/OGYÉI-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for OGYÉI submissions (typically in English/Hungarian)

• Regulatory query response packages

• Method transfer & verification documentation

🇭🇺 Industries We Serve in Hungary

• 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:

• Hungary domestic approvals (Market Authorization from OGYÉI)

• Manufacturing licenses & product permissions

• Export dossiers within the EU/EEA and internationally

🇭🇺 Partner with VALIDEX – Hungary

Achieve OGYÉI-ready analytical validation with confidence.

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