Ensuring Accuracy. Compliance. Regulatory Confidence for Bangladesh Regulatory Submissions

Ensuring Accuracy. Compliance. Regulatory Confidence for Bangladesh 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 Bangladeshi regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Bangladesh with DGDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Directorate General of Drug Administration (DGDA) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Bangladesh Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Directorate General of Drug Administration (DGDA), Ministry of Health & Family Welfare, Government of Bangladesh.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DGDA Bangladesh
• Accuracy, precision, linearity, robustness, and specificity
• IP / USP / BP / EP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation in line with DGDA Bangladesh and ICH expectations

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by DGDA Bangladesh
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Bangladesh

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

Regulatory Compliance – Bangladesh

All Analytical Method Validation activities are conducted in accordance with:

• Directorate General of Drug Administration (DGDA), Bangladesh guidelines
• Drugs Act and Drugs Rules of Bangladesh
• National Drug Policy of Bangladesh
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles recognized by DGDA Bangladesh
• Recognized pharmacopoeias (IP, USP, BP, EP)

Post-Submission Regulatory Support – Bangladesh

VALIDEX provides complete DGDA Bangladesh query management, including:

✅ Responses to DGDA deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap analysis and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during DGDA inspections, audits, and product evaluations

Why Choose VALIDEX for Bangladesh?

✔ Strong understanding of Bangladesh DGDA regulatory expectations
✔ ICH-aligned, DGDA-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Bangladesh registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Bangladesh

• Analytical Method Validation Protocols (Bangladesh-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for DGDA Bangladesh submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Bangladesh

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Export-oriented pharmaceutical units
• Regulatory and dossier consulting firms

National & Export Support – Bangladesh

VALIDEX supports Analytical Method Validation for:

• Bangladesh domestic product registration (DGDA)
• Import registration and marketing authorization
• Export dossiers prepared for submission to Bangladesh
• WHO-tender and government supply registrations

Partner with VALIDEX – Bangladesh

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