Analytical Method Validation Services – Uganda

Ensuring Accuracy. Compliance. Regulatory Confidence for Uganda 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 Ugandan regulatory requirements.

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

Our Core Expertise – Uganda Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the National Drug Authority (NDA) under the Ministry of Health, Republic of Uganda.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Uganda

✅ 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 – Uganda

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• NDA Registration Guidelines & Technical Requirements
• National Drug Policy and Authority Act, Cap. 206 (Uganda)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by NDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Uganda

VALIDEX provides complete NDA query management, including:

✅ Responses to NDA 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 NDA dossier reviews, GMP inspections, and audits

Why Choose VALIDEX for Uganda?

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

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

Industries We Serve in Uganda

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

National & Export Support – Uganda

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Uganda

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