🇸🇩 Bioavailability & Bioequivalence (BA/BE) Studies Services for Sudan
NMPB-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of Sudan’s National Medicines and Poisons Board (NMPB).
All studies adhere strictly to NMPB guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring full compliance for Sudanese pharmaceutical registration and international submissions.
💊 Core Services for Sudan (NMPB) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel designs approved by NMPB.
• Volunteer Selection: Healthy volunteers or patient cohorts depending on therapeutic indication.
• Ethics Approval: Required approval from a recognized Institutional Review Board (IRB)/Ethics Committee in Sudan.
• Protocol Development: NMPB-aligned BA/BE protocols created according to ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic applications, post-approval variations, and equivalence submissions.
• Dissolution Media: Pharmacopeial and biorelevant media.
• Similarity Evaluation: f2 similarity factor used for dissolution profile comparison.
• Evaluation Approaches: Both model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and scientific criteria accepted by NMPB.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Modeling: Supports regulatory justification for biowaivers or reduced clinical requirements.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV platforms for accurate quantitative analysis.
• Validation: Conducted as per ICH M10, WHO TRS, and NMPB-compatible validation standards.
• Stability-Indicating Methods: Developed for APIs and finished formulations.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Performed per WHO and ICH harmonized BE methods recognized by NMPB.
• Sample Size & Power: Calculated to ensure statistically reliable BE outcomes.
📑 NMPB Sudan–Ready Regulatory Documentation
We prepare complete drug registration documentation tailored to the National Medicines and Poisons Board, including:
• Clinical Study Protocol (Sudan-compliant)
• Informed Consent Forms (ICF) aligned with national ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for NMPB submissions
✨ Why Choose BioEquiGlobal for the Sudanese Market?
• Sudan Regulatory Expertise: BE protocols, PK analysis, dissolution profiles, and CTD dossier preparation aligned with NMPB expectations.
• High Global Standards: Compliance with GCP, GLP, WHO TRS, and ICH guidelines backed by strong internal QA frameworks.
• Modern Analytical & Clinical Facilities: Accredited clinical units and advanced analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Capability: Preparation of CTD/ACTD submissions for NMPB and international agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Sudan
Feasibility & Gap Assessment: Review of reference product availability, dissolution suitability, and biowaiver eligibility.
Protocol Development: Drafting NMPB-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation according to ICH M10 & WHO TRS.
Clinical Execution: GCP-guided recruitment, dosing, blood sampling, and continuous safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of NMPB-ready CSR, dissolution report, validation packages, and CTD/ACTD modules.
Who We Support
• Sudanese pharmaceutical manufacturers seeking NMPB regulatory approval
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing NMPB-compliant CTD/ACTD dossiers