Analytical Method Validation Services – Mozambique

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

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

Our Core Expertise – Mozambique Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Autoridade Nacional Reguladora de Medicamentos (ANARME) under the Ministry of Health, Republic of Mozambique.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Mozambique

✅ 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 – Mozambique

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ANARME Registration Guidelines & Technical Requirements
• Mozambique Pharmaceutical Law & Public Health Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by ANARME)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Mozambique

VALIDEX provides complete ANARME query management, including:

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

Why Choose VALIDEX for Mozambique?

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

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

Industries We Serve in Mozambique

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

National & Export Support – Mozambique

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Mozambique

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