🇫🇷 Analytical Method Validation Services – France

Assurer l'Exactitude, la Conformité et la Confiance Réglementaire pour les Soumissions à l'ANSM (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the ANSM)

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 France's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across France with compliance aligned with the French National Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé - ANSM), ICH-aligned documentation, and post-submission handling of ANSM queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇫🇷 Our Core Expertise – France Focus

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

• ✅ Assay Method Validation (Validation de la Méthode d'Essai)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validation de la Méthode d'Impuretés)

  • 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 (Validation de la Méthode de Dissolution)

  • 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 (Validation de la Méthode des Solvants Résiduels)

  • 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 – France

• ✅ 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 – France

All Analytical Method Validation activities are conducted in accordance with:

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

• ANSM Regulations and French 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 (France)

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

• ✅ Response to ANSM deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇫🇷 Why Choose VALIDEX for France?

• ✔ Strong understanding of the ANSM's regulatory interpretation and strict adherence to EU/EMA standards, leveraging France's influence in the EU regulatory network.

• ✔ 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 – France

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for ANSM submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇫🇷 Industries We Serve in France

• 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:

• France domestic approvals (Market Authorization from ANSM).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇫🇷 Partner with VALIDEX – France

Achieve ANSM-ready analytical validation with confidence.

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