Analytical Method Validation Services – Botswana

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

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

Our Core Expertise – Botswana Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Botswana Medicines Regulatory Authority (BoMRA) under the Ministry of Health, Republic of Botswana.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Botswana

✅ 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 – Botswana

All Analytical Method Validation activities are conducted in accordance with:

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

Post-Submission Regulatory Support – Botswana

VALIDEX provides complete BoMRA query management, including:

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

Why Choose VALIDEX for Botswana?

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

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

Industries We Serve in Botswana

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

National & Export Support – Botswana

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Botswana

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