Analytical Method Validation Services – Fiji

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

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

Our Core Expertise – Fiji Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Fiji Medicines Authority (FMA) under the Ministry of Health and Medical Services, Government of Fiji.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Fiji

✅ 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 – Fiji

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Fiji Medicines Authority Registration Guidelines
• Medicines Act & Medicines Regulations of Fiji
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by FMA
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Fiji

VALIDEX provides complete FMA query management, including:

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

Why Choose VALIDEX for Fiji?

✔ Strong understanding of FMA 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 – Fiji

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

Industries We Serve in Fiji

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Fiji

VALIDEX supports Analytical Method Validation for:

• Fiji domestic product registration (FMA)
• Manufacturing and import authorization applications
• Export dossiers prepared for FMA-regulated and WHO-referenced markets

Partner with VALIDEX – Fiji

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