Analytical Method Validation Services – Chile

Ensuring Accuracy. Compliance. Regulatory Confidence for Chile 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 Chile’s regulatory requirements.

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

Our Core Expertise – Chile Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Institute of Public Health of Chile (ISP).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by ISP Chile
• 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 ISP & 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 Chile product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Chile

✅ 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 – Chile

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ISP Technical & Registration Requirements
• Chilean Sanitary Code (Código Sanitario)
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by ISP
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Chile

VALIDEX provides complete ISP query management, including:

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

Why Choose VALIDEX for Chile?

✔ Strong understanding of ISP & 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 – Chile

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

Industries We Serve in Chile

• 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 – Chile

VALIDEX supports Analytical Method Validation for:

• Chile domestic product registration (ISP)
• Manufacturing and import authorization applications
• Export dossiers prepared for Chile, Andean region, and WHO-referenced markets

Partner with VALIDEX – Chile

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