Analytical Method Validation Services – Bhutan

Ensuring Accuracy. Compliance. Regulatory Confidence for Bhutan 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 Bhutanese regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Bhutan with DRA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Drug Regulatory Authority (DRA) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Bhutan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Drug Regulatory Authority (DRA), Ministry of Health, Royal Government of Bhutan.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DRA Bhutan
• 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 DRA Bhutan 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 DRA Bhutan product registration requirements

✅ Residual Solvents Method Validation

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

Products Covered – Bhutan

✅ 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 – Bhutan

All Analytical Method Validation activities are conducted in accordance with:

• Drug Regulatory Authority (DRA), Bhutan guidelines
• Medicines Act of the Kingdom of Bhutan
• Bhutan Medicines Rules and Regulations (BMRR)
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP principles adopted by DRA Bhutan
• Recognized pharmacopoeias (IP, USP, BP, EP)

Post-Submission Regulatory Support – Bhutan

VALIDEX provides complete DRA Bhutan query management, including:

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

Why Choose VALIDEX for Bhutan?

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

Our Deliverables – Bhutan

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

Industries We Serve – Bhutan

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

National & Export Support – Bhutan

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Bhutan

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