🇳🇱 Analytical Method Validation Services – Netherlands

Zorgen voor Nauwkeurigheid, Naleving en Regulerend Vertrouwen voor Indienen bij het CBG (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the CBG)

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 Netherlands' regulatory requirements.

We support pharmaceutical manufacturers and suppliers across the Netherlands with compliance aligned with the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen - CBG), ICH-aligned documentation, and post-submission handling of CBG queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇳🇱 Our Core Expertise – Netherlands Focus

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

• ✅ Assay Method Validation (Validatie van de Assay Methode)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validatie van de Onzuiverheidsmethode)

  • 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 (Validatie van de Oplossingsmethode)

  • 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 (Validatie van de Resterende Oplosmiddelen Methode)

  • 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 – Netherlands

• ✅ 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 – Netherlands

All Analytical Method Validation activities are conducted in accordance with:

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

• CBG (Medicines Evaluation Board) Regulations and Dutch 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 (Netherlands)

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

• ✅ Response to CBG deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇳🇱 Why Choose VALIDEX for the Netherlands?

• ✔ Strong understanding of the CBG's regulatory interpretation and strict adherence to EU/EMA standards, benefiting from the Netherlands' role as the host country for the EMA.

• ✔ 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 – Netherlands

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for CBG submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇳🇱 Industries We Serve in the Netherlands

• 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:

• Netherlands domestic approvals (Market Authorization from CBG).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇳🇱 Partner with VALIDEX – Netherlands

Achieve CBG-ready analytical validation with confidence.

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