🇧🇷 Analytical Method Validation Services – Brazil

Garantindo Precisão. Conformidade. Confiança Regulatória para Submissões no Brasil

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 Brazil's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Brazil with compliance aligned with the Agência Nacional de Vigilância Sanitária (ANVISA), ICH-aligned documentation, and post-submission handling of ANVISA queries for medicine registration, licensing, and certification (e.g., CBPF - Certificado de Boas Práticas de Fabricação).

🇧🇷 Our Core Expertise – Brazil Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by ANVISA, particularly RDC 166/2017 (on Validation of Analytical and Bioanalytical Methods), and internationally accepted pharmacopoeial standards.

• ✅ Assay Method Validation (Validação de Método de Dose)

  • Potency and content determination

  • Validation strictly as per ANVISA RDC 166/2017 and ICH Q2 (R1 / R2) expectations

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

  • Farmacopeia Brasileira (FB)/USP/EP harmonized methods

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

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

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

• ✅ Dissolution Method Validation (Validação de Método de Dissolução)

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with ANVISA product registration requirements (often using the Common Technical Document - CTD structure).

• ✅ Residual Solvents Method Validation (Validação de Método de Solventes Residuais)

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally, aligned with ANVISA quality expectations

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇧🇷 Products Covered – Brazil

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachês)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇧🇷 Regulatory Compliance – Brazil

All Analytical Method Validation activities are conducted in accordance with:

• ANVISA RDC 166/2017 (and subsequent updates)

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

• Boas Práticas de Fabricação (BPF) - RDC 301/2019

• Farmacopeia Brasileira (FB)

• United States Pharmacopeia (USP) and European Pharmacopoeia (EP) (where applicable)

🇧🇷 Post-Submission Regulatory Support (Brazil)

VALIDEX provides complete regulatory query management, assisting with responses to ANVISA and other competent authorities, including:

• ✅ Response to ANVISA exigências (deficiency letters)

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits (e.g., for CBPF)

🇧🇷 Why Choose VALIDEX for Brazil?

• ✔ Strong understanding of ANVISA's specific regulatory requirements and RDCs

• ✔ ICH-aligned documentation focused on Brazilian 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 – Brazil

• Analytical Method Validation Protocols (ANVISA-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• Technical reports and summaries for ANVISA submissions (CTD structure)

• Regulatory query response packages

• Method transfer & verification documentation

🇧🇷 Industries We Serve in Brazil

• Pharmaceutical manufacturing companies (Indústrias Farmacêuticas)

• API traders 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:

• Brazil domestic approvals (Registro de Medicamento - Market Authorization from ANVISA)

• Manufacturing licenses & product permissions

• Export dossiers from Brazil

🇧🇷 Partner with VALIDEX – Brazil

Achieve ANVISA-ready analytical validation with confidence.

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