Analytical Method Validation Services – Trinidad & Tobago

Ensuring Accuracy. Compliance. Regulatory Confidence for Trinidad & Tobago 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 Trinidad & Tobago regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Trinidad & Tobago with CFDD-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 – Trinidad & Tobago Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Chemistry, Food and Drugs Division (CFDD) under the Ministry of Health, Republic of Trinidad & Tobago.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Trinidad & Tobago

✅ 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 – Trinidad & Tobago

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• CFDD Drug Registration & Technical Requirements
• Food and Drugs Act & Regulations of Trinidad & Tobago
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by CFDD
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Trinidad & Tobago

VALIDEX provides complete CFDD query management, including:

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

Why Choose VALIDEX for Trinidad & Tobago?

✔ Strong understanding of Caribbean & 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 – Trinidad & Tobago

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

Industries We Serve in Trinidad & Tobago

• 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 – Trinidad & Tobago

VALIDEX supports Analytical Method Validation for:

• Trinidad & Tobago domestic product registration (CFDD)
• Manufacturing and import authorization applications
• Export dossiers prepared for Trinidad & Tobago, CARICOM markets, and WHO-referenced procurement programs

Partner with VALIDEX – Trinidad & Tobago

Achieve CFDD-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Trinidad & Tobago.