🇲🇹 Analytical Method Validation Services – Malta

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

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 Malta's regulatory requirements.

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

🇲🇹 Our Core Expertise – Malta Focus

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

• ✅ Assay Method Validation (Validazzjoni tal-Metodu tal-Analiżi)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validazzjoni tal-Metodu tal-Impuritajiet)

  • 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 (Validazzjoni tal-Metodu tax-Xoljiment)

  • 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 (Validazzjoni tal-Metodu tas-Solventi Residwi)

  • 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 – Malta

• ✅ 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 – Malta

All Analytical Method Validation activities are conducted in accordance with:

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

• MRPA (Malta Medicines Authority) 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 (Malta)

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

• ✅ Response to MRPA deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇲🇹 Why Choose VALIDEX for Malta?

• ✔ Strong understanding of the MRPA's regulatory interpretation and strict adherence to EU/EMA standards, acknowledging Malta's specific national requirements within the EU framework.

• ✔ 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 – Malta

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for MRPA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇲🇹 Industries We Serve in Malta

• Pharmaceutical manufacturing companies (especially those serving the EU market).

• 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:

• Malta domestic approvals (Market Authorization from MRPA).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇲🇹 Partner with VALIDEX – Malta

Achieve MRPA-ready analytical validation with confidence.

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