Analytical Method Validation Services – Malawi

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

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

Our Core Expertise – Malawi Focus

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

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Malawi

✅ 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 – Malawi

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• PMRA Registration Guidelines & Technical Requirements
• Pharmacy and Medicines Act, 2019 (Malawi)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by PMRA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Malawi

VALIDEX provides complete PMRA query management, including:

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

Why Choose VALIDEX for Malawi?

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

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

Industries We Serve in Malawi

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

National & Export Support – Malawi

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Malawi

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