🇳🇴 Analytical Method Validation Services – Norway

Sikrer Nøyaktighet, Samsvar og Regulativ Tillit for Innsendinger til Legemiddelverket (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the Norwegian Medicines Agency)

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 Norway's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Norway with compliance aligned with the Norwegian Medicines Agency (Statens legemiddelverk - NOMA), ICH-aligned documentation, and post-submission handling of NOMA queries for Marketing Authorization (MA), manufacturing licenses, and EEA requirements (Norway is part of the EEA, adopting relevant EU pharmaceutical law).

🇳🇴 Our Core Expertise – Norway Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by NOMA and the stringent standards of the European Economic Area (EEA). Norway strictly adheres to the European Pharmacopoeia (Ph. Eur.) and ICH guidelines.

• ✅ Assay Method Validation (Validering av Innholdsbestemmelsesmetode)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validering av Urenhetsmetode)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

  • Stability-indicating method validation as per ICH Q3 and EEA GMP guidelines.

• ✅ Dissolution Method Validation (Validering av Oppløsningsmetode)

  • 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 av Metode for Resterende Løsemidler)

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by the EEA).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇳🇴 Products Covered – Norway

• ✅ 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 – Norway

All Analytical Method Validation activities are conducted in accordance with:

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

• NOMA (Norwegian Medicines Agency) Regulations and national pharmaceutical laws.

• European Pharmacopoeia (Ph. Eur.) and relevant EEA/EU Directives/Regulations.

• EEA Good Manufacturing Practices (GMP).

• United States Pharmacopeia (USP) and British Pharmacopoeia (BP) (where applicable).

🇳🇴 Post-Submission Regulatory Support (Norway)

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

• ✅ Response to NOMA deficiency letters (often regarding CMC data in Module 3).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during NOMA/EEA inspections & audits.

🇳🇴 Why Choose VALIDEX for Norway?

• ✔ Strong understanding of the NOMA's regulatory interpretation and strict adherence to EEA/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 – Norway

• Analytical Method Validation Protocols (EEA/NOMA-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for NOMA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇳🇴 Industries We Serve in Norway

• 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:

• Norway domestic approvals (Market Authorization from NOMA).

• Manufacturing licenses & product permissions.

• Export dossiers within the EEA and internationally.

🇳🇴 Partner with VALIDEX – Norway

Achieve NOMA-ready analytical validation with confidence.

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