🇧🇪 Analytical Method Validation Services – Belgium

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

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 Belgium's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Belgium with compliance aligned with the Federal Agency for Medicines and Health Products (Agence Fédérale des Médicaments et des Produits de Santé - AFMPS / FAGG), ICH-aligned documentation, and post-submission handling of AFMPS queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇧🇪 Our Core Expertise – Belgium Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the AFMPS and the stringent standards of the European Union (EU). Belgium, as a key 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 AFMPS 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 – Belgium

• ✅ 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 – Belgium

All Analytical Method Validation activities are conducted in accordance with:

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

• AFMPS/FAGG Regulations and Belgian 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 (Belgium)

VALIDEX provides complete regulatory query management, assisting with responses to AFMPS (and potentially EMA for centralized procedures, as Belgium is an EMA host) queries and technical review requirements, including:

• ✅ Response to AFMPS deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇧🇪 Why Choose VALIDEX for Belgium?

• ✔ Strong understanding of the AFMPS's regulatory interpretation and strict adherence to EU/EMA standards, benefiting from Belgium's central role in European regulation.

• ✔ 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 – Belgium

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for AFMPS submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇧🇪 Industries We Serve in Belgium

• Pharmaceutical manufacturing companies (especially those involved in export, R&D, and biopharma).

• 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:

• Belgium domestic approvals (Market Authorization from AFMPS).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇧🇪 Partner with VALIDEX – Belgium

Achieve AFMPS-ready analytical validation with confidence.

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