Analytical Method Validation Services – Cuba

Ensuring Accuracy. Compliance. Regulatory Confidence for Cuba 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 Cuban regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, exporters, and state procurement entities targeting Cuba with CECMED-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) queries for product registration, sanitary authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Cuba Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by CECMED, under the Ministry of Public Health (MINSAP), Republic of Cuba.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Cuba

✅ 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 – Cuba

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Cuba

VALIDEX provides complete CECMED query management, including:

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

Why Choose VALIDEX for Cuba?

✔ Strong understanding of CECMED 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 – Cuba

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

Industries We Serve in Cuba

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• State-owned pharmaceutical enterprises
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Cuba

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Cuba

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