🇳🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for Namibia
NMRC-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 the Namibia Medicines and Related Substances Regulatory Council (NMRC).
All studies strictly follow NMRC guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring compliance for Namibia’s pharmaceutical registration system and global regulatory acceptance.
💊 Core Services for Namibia (NMRC) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs approved by NMRC.
• Volunteer Selection: Healthy volunteers or patients depending on product classification.
• Ethics Approval: Approval from a recognized Institutional Review Board (IRB)/Ethics Committee in Namibia.
• Protocol Development: NMRC-aligned BA/BE protocols based on ICH E6 (R2) GCP and WHO TRS.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic submissions, post-approval variations, and quality equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media as per NMRC expectations.
• Similarity Assessment: Use of f2 similarity factor to compare dissolution curves.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared following WHO TRS, ICH Q6A, and NMRC-supported scientific justification.
• IVIVC Models: Level A, B, and C correlation models.
• Predictive PK Modeling: Used for biowaiver justification and BE decision support.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted according to ICH M10, WHO TRS, and NMRC-accepted validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Following ICH and WHO harmonized BE guidelines accepted by NMRC.
• Sample Size & Power: Calculated to ensure statistically reliable BE conclusions.
📑 NMRC-Ready Regulatory Documentation
We prepare complete regulatory documentation tailored to Namibia’s NMRC, including:
• Clinical Study Protocol (Namibia-compliant)
• Informed Consent Forms (ICF) meeting 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 NMRC submission
✨ Why Choose BioEquiGlobal for the Namibian Market?
• Local Regulatory Alignment: BE protocols, PK analyses, dissolution comparisons, and dossier formats compliant with NMRC requirements.
• International Best Practices: Strict adherence to GCP, GLP, WHO TRS, and ICH standards with robust internal QA.
• Advanced Facilities: Accredited clinical units and world-class analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Expertise: Preparation of CTD/ACTD submissions for NMRC and international authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and more.
🗺️ BA/BE Study Workflow for Namibia
Feasibility & Gap Assessment: Review of reference product availability in Namibia and evaluation of biowaiver eligibility.
Protocol Development: Drafting NMRC-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-monitored recruitment, dosing, sampling, and medical safety oversight.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Preparation of NMRC-ready CSR, dissolution profiles, validation documents, and CTD/ACTD modules.
Who We Support
• Namibian pharmaceutical manufacturers seeking NMRC approval
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing NMRC-compliant CTD/ACTD dossiers