🇹🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Tanzania
TMDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory framework of Tanzania’s Tanzania Medicines and Medical Devices Authority (TMDA).
All studies strictly follow TMDA Guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and international regulatory acceptance.
💊 Core Services for Tanzania (TMDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies in crossover or parallel formats recognized by TMDA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic indication.
• Ethics Approval: Required approval from the National Health Research Ethics Committee (NatHREC) or a TMDA-recognized IRB.
• Protocol Development: TMDA-aligned study protocols developed according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Mandatory for generic medicine registration, variations, and post-approval quality evaluations.
• Dissolution Media: Pharmacopeial and biorelevant media recommended by TMDA.
• Similarity Assessment: f2 similarity factor to compare test vs. reference dissolution profiles.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and TMDA-accepted scientific approaches.
• IVIVC Modeling: Level A, B, and C predictive correlation models.
• Predictive PK Modeling: Supports scientifically justified biowaivers and BE assessments.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV instruments for bioanalysis.
• Validation: Conducted according to ICH M10, WHO TRS, and TMDA-acceptable analytical validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Performed according to ICH and WHO BE harmonization guidelines recognized by TMDA.
• Power & Sample Size: Statistically planned to ensure conclusive BE outcomes.
📑 TMDA-Ready Regulatory Documentation
We prepare full regulatory documentation tailored to the Tanzania Medicines and Medical Devices Authority (TMDA), including:
• Clinical Study Protocol (Tanzania-compliant)
• Informed Consent Forms (ICF) aligned with Tanzanian ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS guidelines
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for TMDA submissions
✨ Why Choose BioEquiGlobal for the Tanzanian Market?
• TMDA Regulatory Expertise: BE protocols, PK analyses, dissolution testing, and CTD dossiers tailored to TMDA requirements.
• High Global Standards: Compliance with GCP, GLP, WHO TRS, and ICH guidelines supported by strong internal QA.
• Advanced Facilities: Accredited clinical research units and precision analytical laboratories (including NABL-certified labs where applicable).
• International Submission Capability: Preparation of CTD/ACTD dossiers for TMDA and other global authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Tanzania
Feasibility & Gap Assessment: Review of reference product availability, dissolution requirements, and biowaiver potential.
Protocol Development: Drafting TMDA-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised subject recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of TMDA-ready CSR, dissolution data, validation documents, and CTD/ACTD modules.
Who We Support
• Tanzanian pharmaceutical companies seeking TMDA approval
• CROs requiring BA/BE outsourcing or analytical development
• Regulatory teams needing TMDA-compliant CTD/ACTD dossiers