Analytical Method Validation Services – Guatemala

Ensuring Accuracy. Compliance. Regulatory Confidence for Guatemala 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 Guatemala regulatory requirements.

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

Our Core Expertise – Guatemala Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Public Health and Social Assistance (MSPAS), Republic of Guatemala.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by MSPAS Guatemala
• 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 MSPAS & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity 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 Guatemala sanitary registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Guatemala

✅ 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 – Guatemala

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MSPAS Drug Registration & Technical Requirements
• Guatemalan Health Code (Código de Salud)
• Central American Technical Regulations (RTCA) where applicable
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by MSPAS
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Guatemala

VALIDEX provides complete MSPAS query management, including:

✅ Responses to MSPAS 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 dossier reviews, inspections, and audits

Why Choose VALIDEX for Guatemala?

✔ Strong understanding of Guatemala 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 – Guatemala

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

Industries We Serve in Guatemala

• 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 – Guatemala

VALIDEX supports Analytical Method Validation for:

• Guatemala domestic product registration (Registro Sanitario – MSPAS)
• Manufacturing and import authorization applications
• Export dossiers prepared for Guatemala, Central America, and WHO-referenced markets

Partner with VALIDEX – Guatemala

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