Analytical Method Validation Services – Guinea

Ensuring Accuracy. Compliance. Regulatory Confidence for Guinea 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 Guinean regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Guinea with DNPM-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, import authorization, manufacturing approvals, and export dossiers.

Our Core Expertise – Guinea Focus

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

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DNPM Guinea
• 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 DNPM & WHO expectations
• Compliance with USP / BP impurity limits and WHO TRS

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with DNPM product registration and variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Guinea

✅ 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 – Guinea

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• DNPM Guidelines & National Registration Requirements
• Guinea Public Health Code & Pharmaceutical Regulations
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (as adopted by DNPM)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Guinea

VALIDEX provides complete DNPM query management, including:

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

Why Choose VALIDEX for Guinea?

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

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

Industries We Serve in Guinea

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers & distributors supplying the Guinean market
• Regulatory and dossier consulting firms

National & Export Support – Guinea

VALIDEX supports Analytical Method Validation for:

• Guinea domestic product registration (DNPM)
• Import authorization and product approvals
• Export dossiers prepared for DNPM-regulated markets

Partner with VALIDEX – Guinea

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

If you want, I can also:

• Prepare French-language versions (commonly required for Guinea)

• Align content to DNPM dossier checklists

• Convert this into SEO website pages or brochures

• Create other Africa-specific versions (Senegal, Mali, Côte d’Ivoire, Cameroon, etc.)