🇧🇼 Bioavailability & Bioequivalence (BA/BE) Studies Services for Botswana
BoMRA-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 requirements of the Botswana Medicines Regulatory Authority (BoMRA).
All studies strictly comply with ICH, WHO TRS, GCP, GLP, and BoMRA standards for pharmaceutical product registration, ensuring full regulatory acceptability in Botswana and international markets.
💊 Core Services for Botswana (BoMRA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs accepted by BoMRA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic indication.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee, in accordance with Botswana’s health research regulations.
• Protocol Development: BoMRA-aligned protocols developed based on ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval changes.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Factor: f2 similarity factor analysis to compare test and reference dissolution curves.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent comparison models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and BoMRA-accepted scientific guidelines.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Approaches: Linking dissolution characteristics with in vivo behavior.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV technologies for drug quantification.
• Validation: Conducted in accordance with ICH M10, WHO TRS, and internationally recognized standards compatible with BoMRA expectations.
• Stability Methods: Stability-indicating analytical methods for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Performed according to ICH and WHO harmonized BE standards recognized by BoMRA.
• Sample Size & Power: Calculated for conclusive BE demonstration.
📑 BoMRA-Ready Regulatory Documentation
We prepare complete regulatory documentation for submission to the Botswana Medicines Regulatory Authority (BoMRA), including:
• Clinical Study Protocol (Botswana-compliant)
• Informed Consent Forms (ICF) aligned with Botswana ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for BoMRA registration requirements
✨ Why Choose BioEquiGlobal for the Botswana Market?
• Regulatory Accuracy: All BA/BE protocols, analytical reports, PK analyses, and dossiers tailored to BoMRA expectations.
• High-Quality Standards: Strict compliance with GCP, GLP, WHO, and ICH guidelines supported by robust QA systems.
• Advanced Facilities: Accredited clinical units and high-precision analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Experience: Expertise in preparing CTD submissions for BoMRA and authorities such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Botswana
Feasibility & Gap Assessment: Evaluation of reference product availability in Botswana, dissolution method suitability, and biowaiver eligibility.
Protocol Development: Preparation of BoMRA-compliant BA/BE protocols and facilitation of Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation according to ICH M10 and WHO TRS guidelines.
Clinical Study Execution: GCP-supervised volunteer recruitment, dosing, sampling, and medical oversight.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.
Documentation & Submission: Delivery of BoMRA-ready CSR, dissolution report, validation documents, and CTD/ACTD modules.
Who We Support
• Botswana pharmaceutical manufacturers seeking BoMRA product registration
• CROs requiring BA/BE outsourcing or analytical support
• Regulatory teams needing BoMRA-compliant CTD/ACTD dossiers