Analytical Method Validation Services – Suriname

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

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Suriname with BOG-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Bureau of Public Health (BOG) queries for product registration, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Suriname Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Bureau of Public Health (BOG) under the Ministry of Health, Republic of Suriname, aligned with WHO-referenced expectations.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Suriname

✅ 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 – Suriname

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Bureau of Public Health (BOG) registration & technical requirements
• Suriname Medicines & Public Health Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by BOG
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Suriname

VALIDEX provides complete BOG query management, including:

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

Why Choose VALIDEX for Suriname?

✔ Strong understanding of Suriname & Caribbean 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 – Suriname

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

Industries We Serve in Suriname

• 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 – Suriname

VALIDEX supports Analytical Method Validation for:

• Suriname domestic product registration (BOG)
• Manufacturing and import authorization applications
• Export dossiers prepared for Suriname, CARICOM markets, and WHO-referenced procurement programs

Partner with VALIDEX – Suriname

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