Analytical Method Validation Services – Bolivia

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

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

Our Core Expertise – Bolivia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the Ministry of Health and Sports, Plurinational State of Bolivia.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Bolivia

✅ 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 – Bolivia

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Bolivia

VALIDEX provides complete AGEMED query management, including:

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

Why Choose VALIDEX for Bolivia?

✔ Strong understanding of Bolivia & 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 – Bolivia

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

Industries We Serve in Bolivia

• 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 – Bolivia

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Bolivia

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