🇿🇼 Bioavailability & Bioequivalence (BA/BE) Studies Services for Zimbabwe
MCAZ-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers full-service Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of Zimbabwe’s Medicines Control Authority of Zimbabwe (MCAZ).
All studies strictly adhere to MCAZ Guidelines, WHO TRS, ICH standards, GCP, and GLP, ensuring suitability for Zimbabwean drug registration and broader international submissions.
💊 Core Services for Zimbabwe (MCAZ) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel models accepted by MCAZ.
• Volunteer Selection: Healthy volunteers or patient cohorts, depending on therapeutic class.
• Ethics Approval: Mandatory approval from a recognized Medical Research Council of Zimbabwe (MRCZ)/Ethics Committee.
• Protocol Development: MCAZ-aligned BA/BE protocols designed per ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic registration, formulation modifications, and quality comparison.
• Dissolution Media: Pharmacopeial and biorelevant media.
• Similarity Factor: f2 similarity factor used for dissolution curve comparison.
• Evaluation Approaches: Includes both model-independent (f1, f2) and model-dependent modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and scientific criteria recognized by MCAZ.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports biowaiver justification and BE risk evaluation.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV bioanalytical platforms.
• Validation: Conducted as per ICH M10, WHO TRS, and MCAZ-acceptable analytical guidelines.
• Stability-Indicating Methods: Developed for APIs and finished drug formulations.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using ICH and WHO harmonized BE principles recognized by MCAZ.
• Sample Size & Study Power: Determined to ensure statistically robust BE conclusions.
📑 MCAZ-Ready Regulatory Documentation
We prepare complete regulatory documents for submission to the Medicines Control Authority of Zimbabwe, including:
• Clinical Study Protocol (Zimbabwe-compliant)
• Informed Consent Forms (ICF) meeting national ethics requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for MCAZ submissions
✨ Why Choose BioEquiGlobal for the Zimbabwean Market?
• MCAZ Regulatory Expertise: BE protocols, PK analysis, dissolution reports, and CTD dossier preparation aligned with MCAZ expectations.
• High Quality Standards: All operations conform to GCP, GLP, WHO TRS, and ICH guidelines with strong QA oversight.
• Advanced Research Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Capability: Preparation of CTD/ACTD dossiers for MCAZ and top international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Zimbabwe
Feasibility & Gap Assessment: Review of reference product availability, dissolution requirements, and BCS biowaiver eligibility.
Protocol Development: Drafting MCAZ-compliant BA/BE protocols and facilitating MRCZ ethical approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-based subject recruitment, dosing, sampling, and medical supervision.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of MCAZ-ready CSR, dissolution profiles, validation documents, and CTD/ACTD modules.
Who We Support
• Zimbabwean pharmaceutical manufacturers seeking MCAZ approval
• CROs needing BA/BE outsourcing or analytical services
• Regulatory teams requiring MCAZ-compliant CTD/ACTD dossiers