Analytical Method Validation Services – Angola

Ensuring Accuracy. Compliance. Regulatory Confidence for Angola 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 Angolan regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Angola with ARMED-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 – Angola Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Agência Reguladora de Medicamentos e Tecnologias de Saúde (ARMED) under the Ministry of Health, Republic of Angola.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Angola

✅ 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 – Angola

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ARMED Drug Registration Guidelines & Technical Requirements
• Angolan Pharmaceutical Law & Executive Decrees
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by ARMED)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Angola

VALIDEX provides complete ARMED query management, including:

✅ Responses to ARMED deficiency letters and scientific evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during ARMED dossier reviews, inspections, and audits

Why Choose VALIDEX for Angola?

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

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

Industries We Serve in Angola

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

National & Export Support – Angola

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Angola

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