Analytical Method Validation Services – Jamaica

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

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

Our Core Expertise – Jamaica Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health & Wellness (MOHW) through the Standards & Regulation Division (SRD), in alignment with WHO-referenced expectations.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Jamaica

✅ 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 – Jamaica

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MOHW / Standards & Regulation Division (SRD) registration requirements
• Food and Drugs Act of Jamaica & related regulations
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by Jamaica
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Jamaica

VALIDEX provides complete MOHW/SRD query management, including:

✅ Responses to 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 Jamaica?

✔ Strong understanding of Jamaica & 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 – Jamaica

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

Industries We Serve in Jamaica

• 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 – Jamaica

VALIDEX supports Analytical Method Validation for:

• Jamaica domestic product registration (MOHW / SRD)
• Manufacturing and import authorization applications
• Export dossiers prepared for Jamaica, Caribbean markets, and WHO-referenced procurement programs

Partner with VALIDEX – Jamaica

Achieve MOHW/SRD-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Jamaica.