Analytical Method Validation Services – Venezuela

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

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

Our Core Expertise – Venezuela Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Instituto Nacional de Higiene “Rafael Rangel” (INHRR) under the Ministry of Popular Power for Health (MPPS), Bolivarian Republic of Venezuela.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Venezuela

✅ 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 – Venezuela

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• INHRR Technical & Registration Requirements
• Venezuelan Medicines & Public Health Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by INHRR
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Venezuela

VALIDEX provides complete INHRR query management, including:

✅ Responses to INHRR 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 INHRR dossier reviews, inspections, and audits

Why Choose VALIDEX for Venezuela?

✔ Strong understanding of INHRR & 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 – Venezuela

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

Industries We Serve in Venezuela

• 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 – Venezuela

VALIDEX supports Analytical Method Validation for:

• Venezuela domestic product registration (INHRR)
• Manufacturing and import authorization applications
• Export dossiers prepared for Venezuela, Latin America, and WHO-referenced markets

Partner with VALIDEX – Venezuela

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