🇨🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Cameroon
NMDRA-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 tailored to the regulatory standards of Cameroon’s National Drug and Medical Devices Regulatory Authority (NMDRA).
All studies strictly comply with ICH, WHO TRS, GCP, GLP, and Cameroon's pharmaceutical registration requirements, ensuring acceptability for national and international submissions.
💊 Core Services for Cameroon (NMDRA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models recognized by NMDRA.
• Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic classification.
• Ethics Approval: Approval from a recognized Ethics Committee/IRB in Cameroon.
• Protocol Development: NMDRA-aligned protocols created following ICH E6 (R2) GCP, WHO TRS, and internationally harmonized guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic drug registration and post-approval variations in Cameroon.
• Dissolution Media: Pharmacopeial and biorelevant media.
• Similarity Factor: Calculation of f2 similarity factor for comparing dissolution curves.
• Evaluation Techniques: Model-independent (f1, f2) and model-dependent methodologies.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed according to WHO TRS, ICH Q6A, and NMDRA-recognized requirements.
• IVIVC Modeling: Level A, B, and C correlation models to predict in vivo performance.
• Predictive PK Modeling: Linking dissolution behavior with pharmacokinetics for regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Conducted as per ICH M10, WHO TRS, and standards accepted by NMDRA.
• Stability-Indicating Methods: Developed for APIs and finished products for stability evaluation.
Pharmacokinetic (PK) Analysis
• Approach: Non-compartmental analysis (NCA).
• BE Statistics: Conducted in accordance with WHO and ICH harmonized requirements recognized by NMDRA.
• Study Powering: Sample-size and power calculations tailored to Cameroonian regulatory expectations.
📑 NMDRA-Ready Regulatory Documentation
We prepare complete drug registration documentation aligned with the National Drug and Medical Devices Regulatory Authority (NMDRA), including:
• Clinical Study Protocol (Cameroon-compliant)
• Informed Consent Forms (ICF) aligned with local ethical regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS formats
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules prepared for Cameroon’s regulatory submissions
✨ Why Choose BioEquiGlobal for the Cameroonian Market?
• Regulatory Alignment: BA/BE protocols, PK analyses, dissolution profiling, and dossier documentation tailored to Cameroon’s NMDRA requirements.
• Stringent Quality Systems: Operations aligned with GCP, GLP, WHO, and ICH standards, backed by strong internal QA systems.
• State-of-the-Art Facilities: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Expertise: CTD/ACTD dossier preparation for Cameroon and authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Cameroon
Feasibility & Gap Assessment: Review of available reference products in Cameroon and evaluation of biowaiver suitability.
Protocol Development: Drafting Cameroon-compliant BA/BE study protocols and supporting Ethics Committee approvals.
Analytical Method Development: LC-MS/MS method development and validation per ICH M10 and WHO TRS.
Clinical Execution: Volunteer recruitment, dosing, safety monitoring, and GCP-compliant sample collection.
Bioanalysis & PK Evaluation: Detailed PK calculations, QC checks, and statistical BE assessment.
Documentation & Submission: Preparation of NMDRA-ready CSR, dissolution profile reports, analytical validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical companies in Cameroon seeking NMDRA product registration
• CROs needing BA/BE outsourcing and analytical support
• Regulatory teams requiring NMDRA-compliant CTD/ACTD dossiers