Analytical Method Validation Services – Republic of the Congo (Congo-Brazzaville)

Ensuring Accuracy. Compliance. Regulatory Confidence for Congo 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 Republic of the Congo regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Congo-Brazzaville with DPM-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Direction de la Pharmacie et du Médicament (DPM) queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

Our Core Expertise – Congo Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Direction de la Pharmacie et du Médicament (DPM) under the Ministry of Health and Population, Republic of the Congo.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Congo

✅ 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 – Congo

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• DPM Drug Registration Guidelines & Technical Requirements
• Republic of the Congo Public Health Code & Pharmaceutical Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by DPM)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Congo

VALIDEX provides complete DPM query management, including:

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

Why Choose VALIDEX for Congo?

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

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

Industries We Serve in Congo

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

National & Export Support – Congo

VALIDEX supports Analytical Method Validation for:

• Republic of the Congo domestic product registration (DPM)
• Manufacturing and import authorization applications
• Export dossiers prepared for DPM-regulated and WHO-referenced markets

Partner with VALIDEX – Congo

Achieve DPM-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for the Republic of the Congo.