🇹🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Tunisia
DPM Tunisia–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of Tunisia’s Direction de la Pharmacie et du Médicament (DPM).
All studies strictly adhere to DPM Tunisia guidelines, ICH, WHO TRS, GCP, and GLP, ensuring eligibility for national drug registration and international regulatory submissions.
💊 Core Services for Tunisia (DPM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies in crossover or parallel formats accepted by DPM.
• Volunteer Selection: Healthy volunteers or relevant patient groups depending on therapeutic area.
• Ethics Approval: Approval required from a recognized Comité d'Éthique/IRB in Tunisia.
• Protocol Development: DPM-aligned BE protocols prepared according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic submissions, formulation modifications, and BE justification.
• Dissolution Media: Pharmacopeial and biorelevant media per DPM expectations.
• Similarity Factor: f2 similarity factor used to compare dissolution behavior.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared as per WHO TRS, ICH Q6A, and DPM-supported scientific requirements.
• IVIVC Models: Level A, B, and C correlation models.
• Predictive PK Modeling: Used for biowaiver justification and BE risk assessment.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV systems for accurate quantification.
• Validation: Conducted per ICH M10, WHO TRS, and DPM-compatible standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Statistical assessment aligned with ICH and WHO BE criteria recognized by DPM.
• Sample Size & Study Power: Scientifically justified to ensure conclusive BE results.
📑 Tunisia DPM–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored for Tunisia’s Direction de la Pharmacie et du Médicament, including:
• Clinical Study Protocol (Tunisia-compliant)
• Informed Consent Forms (ICF) meeting national ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for DPM submissions
✨ Why Choose BioEquiGlobal for the Tunisian Market?
• Regulatory Expertise: All protocols, analytical validations, PK analysis, and CTD dossiers aligned with DPM requirements.
• International Quality Compliance: Adherence to GCP, GLP, WHO TRS, and ICH standards, supported by rigorous QA systems.
• Advanced Clinical & Analytical Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Capability: Preparation of CTD/ACTD dossiers for DPM and international agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Tunisia
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution method suitability, and biowaiver eligibility.
Protocol Development: Drafting Tunisia DPM–compliant BA/BE protocols and securing Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-controlled volunteer recruitment, dosing, sampling, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of Tunisia-ready CSR, dissolution reports, validation documentation, and CTD/ACTD modules.
Who We Support
• Tunisian pharmaceutical manufacturers seeking DPM approval
• CROs needing BA/BE outsourcing or analytical services
• Regulatory teams requiring DPM-compliant CTD/ACTD dossiers