🇩🇰 Analytical Method Validation Services – Denmark

Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the DMA

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 Denmark's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Denmark with compliance aligned with the Danish Medicines Agency (Lægemiddelstyrelsen - DMA), ICH-aligned documentation, and post-submission handling of DMA queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇩🇰 Our Core Expertise – Denmark Focus

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

• ✅ Assay Method Validation (Validering af Assay Metode)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validering af Urenhedsmetode)

  • 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 (Validering af Opløsningsmetode)

  • 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 (Validering af Metode for Resterende Opløsningsmidler)

  • 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 – Denmark

• ✅ 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 – Denmark

All Analytical Method Validation activities are conducted in accordance with:

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

• DMA (Danish Medicines Agency) Regulations and 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 (Denmark)

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

• ✅ Response to DMA deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇩🇰 Why Choose VALIDEX for Denmark?

• ✔ Strong understanding of the DMA's rigorous regulatory interpretation and adherence to EU/EMA standards, particularly as a key Nordic authority.

• ✔ 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 – Denmark

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for DMA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇩🇰 Industries We Serve in Denmark

• Pharmaceutical manufacturing companies (especially those involved in R&D and biotech).

• 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:

• Denmark domestic approvals (Market Authorization from DMA).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇩🇰 Partner with VALIDEX – Denmark

Achieve DMA-ready analytical validation with confidence.

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