🇵🇹 Analytical Method Validation Services – Portugal

Garantir a Precisão, Conformidade e Confiança Regulatória para Submissões ao Infarmed (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to Infarmed)

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 Portugal's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Portugal with compliance aligned with the National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde - Infarmed), ICH-aligned documentation, and post-submission handling of Infarmed queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇵🇹 Our Core Expertise – Portugal Focus

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

• ✅ Assay Method Validation (Validação do Método de Doseamento)

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation (Validação do Método de Impurezas)

  • 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 (Validação do Método de Dissolução)

  • 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 (Validação do Método de Solventes Residuais)

  • 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 – Portugal

• ✅ 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 – Portugal

All Analytical Method Validation activities are conducted in accordance with:

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

• Infarmed Regulations and Portuguese 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 (Portugal)

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

• ✅ Response to Infarmed deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

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

🇵🇹 Why Choose VALIDEX for Portugal?

• ✔ Strong understanding of Infarmed's regulatory interpretation and strict adherence to EU/EMA standards, acknowledging their role in the decentralized procedure (DCP) and mutual recognition procedure (MRP).

• ✔ 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 – Portugal

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for Infarmed submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇵🇹 Industries We Serve in Portugal

• 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:

• Portugal domestic approvals (Market Authorization from Infarmed).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇵🇹 Partner with VALIDEX – Portugal

Achieve Infarmed-ready analytical validation with confidence.

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