Analytical Method Validation Services – Sierra Leone

Ensuring Accuracy. Compliance. Regulatory Confidence for Sierra Leone 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 Sierra Leone regulatory requirements.

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

Our Core Expertise – Sierra Leone Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Pharmacy Board of Sierra Leone (PBSL) under the Ministry of Health and Sanitation (MoHS), Republic of Sierra Leone.

✅ Assay Method Validation

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

✅ Residual Solvents Method Validation

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

Products Covered – Sierra Leone

✅ 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 – Sierra Leone

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• PBSL Drug Registration Guidelines & Technical Requirements
• Pharmacy and Drugs Act, 2001 (Sierra Leone)
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by PBSL)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Sierra Leone

VALIDEX provides complete PBSL query management, including:

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

Why Choose VALIDEX for Sierra Leone?

✔ Strong understanding of PBSL regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Sierra Leone
✔ 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 – Sierra Leone

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

Industries We Serve in Sierra Leone

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

National & Export Support – Sierra Leone

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Sierra Leone

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