🇸🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Senegal
DPL Senegal–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 requirements of Senegal’s Direction de la Pharmacie et des Laboratoires (DPL).
All studies strictly adhere to DPL Senegal guidelines, ICH, WHO TRS, GCP, and GLP, ensuring full compliance for national pharmaceutical submissions and international regulatory acceptance.
💊 Core Services for Senegal (DPL) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by DPL.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic class.
• Ethics Approval: Approval from a recognized Comité National d’Éthique/IRB in Senegal.
• Protocol Development: DPL-aligned protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, variations, and equivalence justification.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Evaluation: Calculation of f2 similarity factor to compare dissolution profiles.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and DPL-accepted scientific criteria.
• IVIVC Modeling: Level A, B, and C correlation models for in vitro–in vivo predictability.
• Predictive PK Modeling: Supports biowaiver justification and regulatory decision-making.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems for drug quantification.
• Validation: Conducted as per ICH M10, WHO TRS, and DPL-compatible analytical standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using ICH and WHO harmonized BE methods recognized by DPL.
• Sample Size & Power: Scientifically determined for reliable BE conclusions.
📑 Senegal DPL–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored to Direction de la Pharmacie et des Laboratoires, including:
• Clinical Study Protocol (Senegal-compliant)
• Informed Consent Forms (ICF) aligned with national ethical regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for DPL submissions
✨ Why Choose BioEquiGlobal for the Senegalese Market?
• Regulatory Expertise: BE protocols, PK reports, dissolution studies, and CTD dossiers aligned with DPL Senegal requirements.
• International Standards: Compliance with GCP, GLP, WHO TRS, and ICH guidelines with strong quality assurance frameworks.
• Advanced Clinical & Analytical Facilities: Accredited clinical units and precision analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Preparation: CTD/ACTD submissions for DPL and international agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Senegal
Feasibility & Gap Assessment: Evaluation of reference product availability, biowaiver potential, and dissolution method suitability.
Protocol Development: Drafting DPL-compliant BA/BE study protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-monitored recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE analysis.
Documentation & Submission: Preparation of Senegal-ready CSR, dissolution profile, validation reports, and CTD/ACTD dossier modules.
Who We Support
• Senegalese pharmaceutical manufacturers seeking DPL approval
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing DPL-compliant CTD/ACTD dossiers