Analytical Method Validation Services – Niger
DPM Niger–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory framework of Niger’s Direction de la Pharmacie et de la Médecine Traditionnelle (DPM).
All studies strictly follow DPM Niger guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for local drug registration and international submissions.
💊 Core Services for Niger (DPM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by DPM.
• Volunteer Selection: Healthy volunteers or patient populations depending on therapeutic indication.
• Ethics Approval: Approval required from a recognized Comité National d’Éthique/IRB in Niger.
• Protocol Development: Niger-specific BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Necessary for generic registration, dossier variations, and bioequivalence justification.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media recommended for Niger submissions.
• Similarity Assessment: Calculation of f2 similarity factor to compare test and reference profiles.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared in line with WHO TRS, ICH Q6A, and DPM-accepted scientific guidelines.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory justification for BE waiver or reduced clinical requirements.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV systems for accurate bioanalytical assays.
• Validation: Conducted following ICH M10, WHO TRS, and Niger-relevant validation principles.
• Stability-Indicating Methods: Created for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using WHO and ICH harmonized approaches recognized by DPM.
• Sample Size & Power: Scientifically determined for conclusive BE demonstration.
📑 Niger DPM–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored to the Direction de la Pharmacie et de la Médecine Traditionnelle, including:
• Clinical Study Protocol (Niger-compliant)
• Informed Consent Forms (ICF) aligned with national ethics laws
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for DPM submissions
✨ Why Choose BioEquiGlobal for the Niger Market?
• Regulatory Precision: BE protocol development, analytical methods, PK analysis, and CTD preparation aligned with DPM standards.
• International Quality Systems: Full GCP, GLP, WHO TRS, and ICH compliance supported by strong QA infrastructure.
• Modern Analytical & Clinical Capabilities: Accredited clinical units and high-end analytical laboratories (including NABL-certified facilities where applicable).
• Global Dossier Expertise: CTD/ACTD submissions prepared for DPM and global agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Niger
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution requirements, and biowaiver eligibility.
Protocol Development: Drafting DPM-compliant BA/BE study protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-guided recruitment, dosing, sample collection, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE analysis.
Documentation & Submission: Preparation of Niger DPM–ready CSR, dissolution reports, validation data, and CTD/ACTD modules.
Who We Support
• Niger-based pharmaceutical manufacturers seeking DPM approval
• CROs requiring outsourced BA/BE or analytical services
• Regulatory teams needing DPM-compliant CTD/ACTD dossiersEnsuring Accuracy. Compliance. Regulatory Confidence for Niger 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 Nigerien regulatory requirements.
We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Niger with DPM-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.
Our Core Expertise – Niger 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 Public Health, Republic of Niger.
✅ Assay Method Validation
• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DPM Niger
• 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 Niger
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision
Products Covered – Niger
✅ 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 – Niger
All Analytical Method Validation activities are conducted in accordance with:
• ICH Q2 (R1 / R2)
• DPM Drug Registration Guidelines & Technical Requirements
• Niger 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 – Niger
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 Niger?
✔ Strong understanding of DPM regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Niger
✔ 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 – Niger
• 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 Niger
• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms
National & Export Support – Niger
VALIDEX supports Analytical Method Validation for:
• Niger domestic product registration (DPM)
• Manufacturing and import authorization applications
• Export dossiers prepared for DPM-regulated and WHO-referenced markets
Partner with VALIDEX – Niger
Achieve DPM-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Niger.