Analytical Method Validation Services – Maldives

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

We support pharmaceutical manufacturers, API suppliers, importers, local agents, Marketing Authorization Holders (MAHs), CMOs, and export-oriented companies targeting Maldives with Maldives Food and Drug Authority (MFDA)–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of MFDA queries for product registration, import authorization, and lifecycle management.

Our Core Expertise – Maldives Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Maldives Food and Drug Authority (MFDA), aligned with ICH guidelines and international pharmacopoeias accepted by MFDA.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) accepted by MFDA
• Accuracy, precision, linearity, range, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per MFDA expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D

✅ Dissolution Method Validation

• Immediate-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness studies
• Compliance with MFDA product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by MFDA
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD & LOQ

Products Covered – Maldives

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders)
✅ Liquid oral formulations
✅ Injectable formulations (sterile & non-sterile)
✅ Semi-solid dosage forms
✅ Modified-release & controlled-release products

Regulatory Compliance – Maldives

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Maldives Food and Drug Authority (MFDA) Regulations
• ICH Q3A / Q3B / Q3C / Q3D
• WHO-GMP / EU-GMP / US FDA GMP (accepted for imports)

Post-Submission Regulatory Support – Maldives

VALIDEX provides complete MFDA regulatory query management, including:

✅ Responses to MFDA deficiency letters
✅ Scientific justification for analytical & validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during MFDA technical reviews & inspections

Why Choose VALIDEX for Maldives?

✔ Strong understanding of MFDA regulatory expectations
✔ ICH-aligned, import-focused documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting import registration & MAH dossiers
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Maldives

• Maldives-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / MFDA analytical summaries
• MFDA regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – Maldives

• Pharmaceutical manufacturers exporting to Maldives
• API suppliers
• Importers & local agents
• Marketing Authorization Holders (MAHs)
• Contract Manufacturing Organizations (CMOs)
• Regulatory & dossier consulting firms

Import & Market Access Support – Maldives

VALIDEX supports Analytical Method Validation for:

• MFDA product registration
• Import license & renewal support
• Post-approval variations
• Export dossiers prepared for Maldives from India, EU, US & ASEAN

Partner with VALIDEX – Maldives

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