🇳🇿 Analytical Method Validation Services – New Zealand

Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to Medsafe

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 New Zealand's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across New Zealand with compliance aligned with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), ICH-aligned documentation, and post-submission handling of Medsafe queries for medicine registration, licensing, and import/export requirements.

🇳🇿 Our Core Expertise – New Zealand Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by Medsafe. Medsafe generally accepts standards based on the US, EU, and UK, heavily referencing ICH guidelines and the CTD format for submissions.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with Medsafe expectations.

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

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

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

  • Media selection, sink condition assessment, and method robustness.

  • Compliance with medicine registration requirements, submitted in CTD format.

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by Medsafe).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇳🇿 Products Covered – New Zealand

• ✅ 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 – New Zealand

All Analytical Method Validation activities are conducted in accordance with:

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

• Medsafe Guidelines and the Medicines Act 1981.

• British Pharmacopoeia (BP) and European Pharmacopoeia (Ph. Eur.) (primary references).

• Good Manufacturing Practices (GMP) recognized by Medsafe (often PIC/S or WHO standards).

🇳🇿 Post-Submission Regulatory Support (New Zealand)

VALIDEX provides complete regulatory query management, assisting with responses to Medsafe queries and technical review requirements, including:

• ✅ Response to Medsafe deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during Medsafe inspections & audits.

🇳🇿 Why Choose VALIDEX for New Zealand?

• ✔ Strong understanding of Medsafe's regulatory expectations and adherence to international (BP/EU/US) standards.

• ✔ ICH-aligned documentation focused on New Zealand 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 – New Zealand

• Analytical Method Validation Protocols (Medsafe-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for Medsafe submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇳🇿 Industries We Serve in New Zealand

• 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:

• New Zealand domestic approvals (Medicine Registration from Medsafe).

• Manufacturing licenses & product permissions.

• Export dossiers globally.

🇳🇿 Partner with VALIDEX – New Zealand

Achieve Medsafe-ready analytical validation with confidence.

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