Analytical Method Validation Services – Ecuador

Ensuring Accuracy. Compliance. Regulatory Confidence for Ecuador Regulatory Submissions

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, fully compliant with Ecuador regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Ecuador with ARCSA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of ARCSA queries for product registration (Registro Sanitario), manufacturing/import approvals, and export dossiers.

Our Core Expertise – Ecuador Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) under the Ministry of Public Health, Republic of Ecuador.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by ARCSA Ecuador
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with ARCSA & WHO expectations
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities) and pharmacopoeial limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with Ecuador product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by Ecuador
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Ecuador

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid & liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Ecuador

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ARCSA Drug Registration & Technical Requirements
• Organic Health Law of Ecuador (Ley Orgánica de Salud)
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by ARCSA
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Ecuador

VALIDEX provides complete ARCSA query management, including:

✅ Responses to ARCSA deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during ARCSA dossier reviews, inspections, and audits

Why Choose VALIDEX for Ecuador?

✔ Strong understanding of ARCSA & Andean/Latin America regulatory expectations
✔ ICH-aligned, WHO-compliant documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Ecuador

• Analytical Method Validation Protocols (ARCSA-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for ARCSA submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Ecuador

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Ecuador

VALIDEX supports Analytical Method Validation for:

• Ecuador domestic product registration (Registro Sanitario – ARCSA)
• Manufacturing and import authorization applications
• Export dossiers prepared for Ecuador, Andean Community markets, and WHO-referenced markets

Partner with VALIDEX – Ecuador

Achieve ARCSA-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Ecuador.