🇺🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Uganda
NDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides full-service Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory requirements of Uganda’s National Drug Authority (NDA).
All studies strictly adhere to NDA Guidelines, WHO TRS, ICH standards, GCP, and GLP, ensuring compliance for national drug registration and international submissions.
💊 Core Services for Uganda (NDA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models endorsed by NDA.
• Volunteer Selection: Healthy volunteers or patient populations as required.
• Ethics Approval: Mandatory approval from the Uganda National Council for Science and Technology (UNCST) and an accredited Research Ethics Committee (REC).
• Protocol Development: NDA-aligned protocols designed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration, formulation changes, and post-approval variations.
• Dissolution Media: Pharmacopeial and biorelevant media in line with NDA and WHO expectations.
• Similarity Factor: f2 similarity factor for evaluating dissolution equivalence.
• Evaluation Models: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared based on WHO TRS, ICH Q6A, and NDA-supported guidelines.
• IVIVC Models: Level A, B, and C correlation models for predicting in vivo performance.
• Predictive PK Modeling: Supports decisions related to biowaiver eligibility and regulatory justifications.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV for accurate drug quantification.
• Validation: Conducted according to ICH M10, WHO TRS, and NDA-acceptable scientific standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Applied using WHO & ICH harmonized statistical methods accepted by NDA.
• Study Power: Sample size and power determined to ensure reliable BE conclusions.
📑 NDA Uganda–Ready Regulatory Documentation
We prepare full regulatory documentation for submission to Uganda’s National Drug Authority, including:
• Clinical Study Protocol (Uganda-compliant)
• Informed Consent Forms (ICF) following UNCST ethical norms
• 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 NDA submissions
✨ Why Choose BioEquiGlobal for the Ugandan Market?
• NDA Regulatory Expertise: Thorough understanding of BE, dissolution, and CTD requirements for Uganda.
• Global Quality Standards: Strict adherence to GCP, GLP, WHO TRS, and ICH guidelines with strong internal QA systems.
• Modern Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified platforms).
• International Dossier Capability: CTD/ACTD submissions for NDA and global authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Uganda
Feasibility & Gap Assessment: Review of reference product availability, dissolution method suitability, and biowaiver feasibility.
Protocol Development: Creation of NDA-compliant BA/BE protocols and facilitation of UNCST + REC approvals.
Analytical Method Development: LC-MS/MS method development and validation according to ICH M10 and WHO TRS.
Clinical Execution: GCP-supervised recruitment, dosing, sample collection, and medical monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.
Documentation & Submission: Preparation of NDA-ready CSR, dissolution profile, validation package, and CTD/ACTD modules.
Who We Support
• Ugandan pharmaceutical manufacturers seeking NDA approval
• CROs requiring outsourced BA/BE or analytical solutions
• Regulatory teams needing NDA-compliant CTD/ACTD dossiers