Analytical Method Validation Services – Tanzania

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

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

Our Core Expertise – Tanzania Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Tanzania Medicines and Medical Devices Authority (TMDA) under the Ministry of Health, United Republic of Tanzania.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Tanzania

✅ 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 – Tanzania

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• TMDA Registration Guidelines & Technical Requirements
• Tanzania Medicines and Medical Devices Act
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by TMDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Tanzania

VALIDEX provides complete TMDA query management, including:

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

Why Choose VALIDEX for Tanzania?

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

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

Industries We Serve in Tanzania

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

National & Export Support – Tanzania

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Tanzania

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