Analytical Method Validation Services – Sudan

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

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

Our Core Expertise – Sudan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the National Medicines and Poisons Board (NMPB) under the Federal Ministry of Health (FMoH), Republic of Sudan.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with NMPB & 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 NMPB product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Sudan

✅ 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 – Sudan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• NMPB Drug Registration Guidelines & Technical Requirements
• Pharmacy, Poisons, Cosmetics and Medical Devices Act (Sudan)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by NMPB)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Sudan

VALIDEX provides complete NMPB query management, including:

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

Why Choose VALIDEX for Sudan?

✔ Strong understanding of NMPB regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Sudan
✔ 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 – Sudan

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

Industries We Serve in Sudan

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

National & Export Support – Sudan

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Sudan

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