🇲🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mauritania
DPM-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 aligned to the regulatory requirements of Mauritania’s Direction de la Pharmacie et des Médicaments (DPM).
All studies strictly follow DPM guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring pharmaceutical acceptability for Mauritanian drug registration and global submissions.
💊 Core Services for Mauritania (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-based studies depending on therapeutic purpose.
• Ethics Approval: Approval from a recognized Comité d’Éthique/IRB in Mauritania.
• Protocol Development: DPM-aligned protocols based on ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic drug registration, variations, and equivalence evaluation.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: Use of f2 similarity factor to compare dissolution curves.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and scientific principles recognized by DPM.
• IVIVC Modeling: Level A, B, and C predictive correlation models.
• Predictive PK Modeling: Supports regulatory justification for BE waiver eligibility.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV platforms for precise bioanalytical measurement.
• Validation: Performed according to ICH M10, WHO TRS, and DPM-compatible validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Statistical evaluation following ICH and WHO harmonized standards recognized by DPM.
• Sample Size & Power: Calculated to ensure conclusive BE determination.
📑 DPM Mauritania–Ready Regulatory Documentation
We prepare complete regulatory documents suitable for drug registration with Mauritania’s Direction de la Pharmacie et des Médicaments, including:
• Clinical Study Protocol (Mauritania-compliant)
• Informed Consent Forms (ICF) aligned with national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules prepared for DPM submission
✨ Why Choose BioEquiGlobal for the Mauritanian Market?
• Mauritania-Specific Expertise: BE protocols, PK analysis, dissolution studies, and dossiers tailored to DPM regulations.
• Global Quality Systems: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines.
• Advanced Infrastructure: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities).
• International Dossier Capability: CTD/ACTD submissions for DPM and other global regulators including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Mauritania
Feasibility & Gap Assessment: Review of reference product availability and biowaiver potential.
Protocol Development: Drafting DPM-compliant BA/BE protocols and facilitation of Ethics Committee approvals.
Analytical Method Development: LC-MS/MS method creation and validation according to ICH M10 and WHO TRS.
Clinical Execution: GCP-based volunteer recruitment, dosing, sampling, and safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of DPM-ready CSR, dissolution reports, method validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Mauritania seeking DPM approval
• CROs needing outsourced BA/BE or analytical services
• Regulatory teams requiring DPM-compliant CTD/ACTD dossiers