🇬🇷 Analytical Method Validation Services – Greece

Διασφάλιση Ακρίβειας, Συμμόρφωσης και Ρυθμιστικής Εμπιστοσύνης για Υποβολές στον ΕΟΦ (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to EOF)

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 Greece's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Greece with compliance aligned with the National Organisation for Medicines (Εθνικός Οργανισμός Φαρμάκων - EOF), ICH-aligned documentation, and post-submission handling of EOF queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇬🇷 Our Core Expertise – Greece Focus

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

• ✅ Assay Method Validation (Επικύρωση Μεθόδου Προσδιορισμού Περιεκτικότητας)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Επικύρωση Μεθόδου Προσδιορισμού Προσμείξεων)

  • 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 (Επικύρωση Μεθόδου Διάλυσης)

  • 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 (Επικύρωση Μεθόδου Υπολειμματικών Διαλυτών)

  • 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 – Greece

• ✅ 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 – Greece

All Analytical Method Validation activities are conducted in accordance with:

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

• EOF (National Organisation for Medicines) Regulations and Greek 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 (Greece)

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

• ✅ Response to EOF deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇬🇷 Why Choose VALIDEX for Greece?

• ✔ Strong understanding of the EOF'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 – Greece

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for EOF submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇬🇷 Industries We Serve in Greece

• 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:

• Greece domestic approvals (Market Authorization from EOF).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇬🇷 Partner with VALIDEX – Greece

Achieve EOF-ready analytical validation with confidence.

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