🇨🇴 Analytical Method Validation Services – Colombia

Garantizando Precisión. Conformidad. Confianza Regulatória para las Solicitudes INVIMA

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 Colombia's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Colombia with compliance aligned with the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), ICH-aligned documentation, and post-submission handling of INVIMA queries for sanitary registration, manufacturing licenses, and import/export requirements.

🇨🇴 Our Core Expertise – Colombia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by INVIMA (the equivalent of the FDA), referencing ICH guidelines and recognized pharmacopoeial standards.

• ✅ Assay Method Validation (Validación de la Metodología de Ensayo)

  • Potency and content determination

  • Validation as per ICH Q2 guidelines, aligned with INVIMA's technical review process

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

  • Farmacopea (USP/EP/BP) methods, with verification of suitability required

• ✅ Impurities Method Validation (Validación de la Metodología de Impurezas)

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH Q3 and INVIMA expectations

• ✅ Dissolution Method Validation (Validación de la Metodología de Disolución)

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with product registration requirements, usually submitted in CTD format.

• ✅ Residual Solvents Method Validation (Validación de la Metodología de Solventes Residuales)

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally, aligning with INVIMA's quality requirements

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇨🇴 Products Covered – Colombia

• ✅ 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 – Colombia

All Analytical Method Validation activities are conducted in accordance with:

• INVIMA Guidelines and relevant Decrees/Resolutions (e.g., Decree 677/1995)

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

• Buenas Prácticas de Manufactura (BPM) / GMP (Resolution 3183/1995, etc.)

• Official Compendia (USP, EP, BP, etc.)

🇨🇴 Post-Submission Regulatory Support (Colombia)

VALIDEX provides complete regulatory query management, assisting with responses to INVIMA exigencies (deficiency letters) and requests, including:

• ✅ Response to INVIMA deficiency letters (often focusing on CMC data)

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇨🇴 Why Choose VALIDEX for Colombia?

• ✔ Strong understanding of INVIMA's complex regulatory requirements and expedited review processes for certain submissions

• ✔ ICH-aligned documentation focused on Colombian national compliance norms, submitted in Spanish

• ✔ 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 – Colombia

• Analytical Method Validation Protocols (INVIMA-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• Technical reports and summaries for INVIMA submissions (in Spanish where required)

• Regulatory query response packages

• Method transfer & verification documentation

🇨🇴 Industries We Serve in Colombia

• Pharmaceutical manufacturing companies

• 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:

• Colombia domestic approvals (Registro Sanitario from INVIMA)

• Manufacturing licenses & product permissions

• Export dossiers from Colombia

🇨🇴 Partner with VALIDEX – Colombia

Achieve INVIMA-ready analytical validation with confidence.

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