🇨🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for the Republic of the Congo
DPM Congo–Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory framework of the Direction de la Pharmacie et du Médicament (DPM Congo).
All studies comply with DPM Congo guidelines, ICH, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and international submissions.
💊 Core Services for Republic of the Congo (DPM) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel formats recognized by DPM.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on the therapeutic class.
• Ethics Approval: Required approval from a recognized Comité National d’Éthique/IRB in the Republic of the Congo.
• Protocol Development: DPM-aligned BA/BE protocols prepared according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, formulation changes, and therapeutic equivalence demonstration.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor for comparing test vs. reference products.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution analysis.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and scientific standards accepted by DPM Congo.
• IVIVC Models: Level A, B, and C models for in vitro–in vivo correlation.
• Predictive PK Modeling: Supports biowaiver justification and enhanced regulatory decision-making.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted per ICH M10, WHO TRS, and DPM-compatible guidelines.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: As per ICH and WHO harmonized BE guidelines recognized by DPM.
• Sample Size & Power: Scientifically determined for statistically robust BE studies.
📑 DPM Congo–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored for the Direction de la Pharmacie et du Médicament (DPM Congo), including:
• Clinical Study Protocol (Congo-compliant)
• Informed Consent Forms (ICF) meeting national ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) compliant with ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules structured for DPM submission
✨ Why Choose BioEquiGlobal for the Congolese Market?
• Regulatory Expertise: BE protocols, PK analysis, dissolution studies, and dossier formatting aligned with DPM Congo requirements.
• Strong Quality Systems: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines supported by robust QA frameworks.
• Advanced Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities).
• Global Dossier Capability: CTD/ACTD submissions suitable for DPM and international regulators including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for the Republic of the Congo
Feasibility & Gap Assessment: Reference product availability, dissolution evaluation, and biowaiver feasibility.
Protocol Development: Drafting DPM-compliant BA/BE protocols and obtaining Ethics Committee approval.
Analytical Method Development: LC-MS/MS assay development 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 BE statistical assessment.
Documentation & Submission: Preparation of Congo-ready CSR, CDP report, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in the Republic of the Congo seeking DPM approval
• CROs requiring outsourced BA/BE studies or analytical services
• Regulatory teams needing DPM-compliant CTD/ACTD dossiers