Analytical Method Validation Services – Guyana

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

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

Our Core Expertise – Guyana Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Food and Drug Department (FDD) under the Ministry of Health, Cooperative Republic of Guyana, aligned with WHO-referenced expectations.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Guyana

✅ 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 – Guyana

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Food and Drug Department (FDD) Registration & Technical Requirements
• Food and Drugs Act of Guyana & associated regulations
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by FDD
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Guyana

VALIDEX provides complete FDD query management, including:

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

Why Choose VALIDEX for Guyana?

✔ Strong understanding of Guyana & Caribbean 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 – Guyana

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

Industries We Serve in Guyana

• 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 – Guyana

VALIDEX supports Analytical Method Validation for:

• Guyana domestic product registration (FDD)
• Manufacturing and import authorization applications
• Export dossiers prepared for Guyana, CARICOM markets, and WHO-referenced procurement programs

Partner with VALIDEX – Guyana

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