🇿🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Zambia
ZAMRA-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 with the regulatory requirements of Zambia’s Zambia Medicines Regulatory Authority (ZAMRA).
All studies strictly follow ZAMRA guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for pharmaceutical submissions in Zambia and international markets.
💊 Core Services for Zambia (ZAMRA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel study designs accepted by ZAMRA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on the therapeutic area.
• Ethics Approval: Approval from a recognized National Health Research Authority (NHRA)/Ethics Committee in Zambia.
• Protocol Development: ZAMRA-aligned protocols developed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration, product variations, and quality comparison.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: Calculation of f2 similarity factor for dissolution comparison.
• Evaluation Approaches: Includes model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and ZAMRA-compatible scientific guidelines.
• IVIVC Models: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory decision-making and biowaiver justification.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: As per ICH M10, WHO TRS, and ZAMRA-recognized validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using WHO and ICH harmonized statistical approaches accepted by ZAMRA.
• Sample Size & Power: Scientifically determined to ensure reliable BE results.
📑 ZAMRA-Ready Regulatory Documentation
We prepare complete documentation suitable for submission to Zambia’s ZAMRA, including:
• Clinical Study Protocol (Zambia-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 (1–5) formatted for ZAMRA submissions
✨ Why Choose BioEquiGlobal for the Zambian Market?
• ZAMRA Regulatory Expertise: All protocols, analytical validations, PK analysis, and CTD dossiers tailored to ZAMRA requirements.
• High Global Standards: Full compliance with GCP, GLP, WHO TRS, and ICH guidelines supported by robust QA systems.
• Advanced Infrastructure: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Submission Flexibility: CTD/ACTD dossiers prepared for ZAMRA and major regulators including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Zambia
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution suitability, and biowaiver eligibility.
Protocol Development: Drafting ZAMRA-compliant BA/BE protocols and assisting with NHRA ethics approval.
Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS.
Clinical Execution: GCP-supervised recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK calculation, QC checks, and BE statistical assessment.
Documentation & Submission: Preparation of ZAMRA-ready CSR, dissolution reports, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Zambia seeking ZAMRA approval
• CROs requiring outsourced BA/BE or analytical services
• Regulatory teams needing ZAMRA-compliant CTD/ACTD dossiers