Analytical Method Validation Services – Zimbabwe

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

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

Our Core Expertise – Zimbabwe Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Medicines Control Authority of Zimbabwe (MCAZ) under the Ministry of Health and Child Care, Republic of Zimbabwe.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Zimbabwe

✅ 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 – Zimbabwe

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MCAZ Registration Guidelines & Technical Requirements
• Medicines and Allied Substances Control Act (Zimbabwe)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by MCAZ)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Zimbabwe

VALIDEX provides complete MCAZ query management, including:

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

Why Choose VALIDEX for Zimbabwe?

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

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

Industries We Serve in Zimbabwe

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

National & Export Support – Zimbabwe

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Zimbabwe

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