Analytical Method Validation Services – Haiti

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

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, exporters, NGOs, and public health procurement agencies targeting Haiti with MSPP-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Ministry of Public Health and Population (MSPP) queries for product registration, sanitary authorization, manufacturing/import approvals, and donor-funded supply dossiers.

Our Core Expertise – Haiti Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Public Health and Population (MSPP), Republic of Haiti, in alignment with WHO-referenced regulatory expectations.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Haiti

✅ 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 – Haiti

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MSPP Drug Registration & Sanitary Authorization Requirements
• Haitian Public Health Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by MSPP
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Haiti

VALIDEX provides complete MSPP query management, including:

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

Why Choose VALIDEX for Haiti?

✔ Strong understanding of Haiti & WHO-aligned 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 – Haiti

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

Industries We Serve in Haiti

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• NGOs & humanitarian health suppliers
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Haiti

VALIDEX supports Analytical Method Validation for:

• Haiti domestic product registration (MSPP)
• Manufacturing and import authorization applications
• Export dossiers prepared for Haiti, Caribbean markets, and WHO-referenced procurement programs

Partner with VALIDEX – Haiti

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