🇨🇩 Analytical Method Validation Services – Democratic Republic of the Congo (DRC)

Ensuring Accuracy. Compliance. Regulatory Confidence for DRC 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 in full compliance with the Democratic Republic of the Congo (DRC) regulatory requirements.

We support pharmaceutical manufacturers and suppliers across the DRC with compliance aligned with the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP), ICH-aligned documentation, and post-submission handling of ACOREP queries for drug registration, licensing, and import/export requirements.

🇨🇩 Our Core Expertise – DRC Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Congolese Pharmaceutical Regulatory Authority (ACOREP) and internationally accepted pharmacopoeial standards, often following guidelines from WHO and regional harmonization efforts.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with ACOREP and regional quality expectations

  • Accuracy, precision, linearity, robustness, and specificity

  • BP/USP/EP harmonized methods

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH and WHO-GMP

• ✅ Dissolution Method Validation

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with product registration requirements, following international norms (CTD format)

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally, aligning with ACOREP's quality expectations

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇨🇩 Products Covered – DRC

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachets)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇨🇩 Regulatory Compliance – DRC

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• ACOREP Guidelines and national pharmaceutical regulations

• WHO-GMP recommendations, widely accepted in the region

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

• British Pharmacopoeia (BP)

• Principles of the African Medicines Regulatory Harmonisation (AMRH) Initiative

🇨🇩 Post-Submission Regulatory Support (DRC)

VALIDEX provides complete regulatory query management, assisting with responses to ACOREP and other competent authorities, including:

• ✅ Response to regulatory deficiency letters

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇨🇩 Why Choose VALIDEX for DRC?

• ✔ Strong understanding of DRC's ACOREP regulatory expectations and regional standards

• ✔ ICH-aligned documentation focused on African and international compliance norms

• ✔ Inspection-ready and audit-compliant validation reports

• ✔ Fast turnaround timelines

• ✔ Strict confidentiality & data integrity

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

🇨🇩 Our Deliverables – DRC

• Analytical Method Validation Protocols (ACOREP-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for ACOREP submissions (Dossiers must be in French)

• Regulatory query response packages

• Method transfer & verification documentation

🇨🇩 Industries We Serve in DRC

• Pharmaceutical manufacturing companies

• API traders and importers

• Generic formulation companies

• Contract Manufacturing Organizations (CMOs)

• Import and Distribution companies

• Regulatory & dossier consulting firms

🇨🇩 National & Export Support

VALIDEX supports Analytical Method Validation for:

• DRC domestic approvals (Market Authorization from ACOREP)

• Manufacturing licenses & product permissions

• Export dossiers for regional and international shipment from the DRC

🇨🇩 Partner with VALIDEX – DRC

Achieve ACOREP-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in the Democratic Republic of the Congo.