🇲🇼 BA/BE Studies Services for Malawi (PMRA-Compliant)
PMRA-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 tailored to the regulatory requirements of Malawi’s Pharmacy and Medicines Regulatory Authority (PMRA).
All studies strictly follow PMRA guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring full compliance for Malawi’s drug registration system and international regulatory markets.
💊 Core Services for Malawi (PMRA) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models accepted by PMRA.
• Volunteer Selection: Healthy volunteers or patient populations depending on therapeutic category.
• Ethics Approval: Approval from a nationally recognized Institutional Review Board (IRB)/Ethics Committee in Malawi.
• Protocol Development: PMRA-aligned protocols designed according to ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic product registration, post-approval changes, and quality re-evaluation.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor used to compare dissolution profiles of test and reference products.
• Evaluation Methods: Both model-independent (f1, f2) and model-dependent dissolution modeling approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared using WHO TRS, ICH Q6A, and PMRA-acceptable scientific justification.
• IVIVC Modeling: Level A, B, and C correlation models for predicting in vivo drug performance.
• Predictive PK Modeling: Dissolution–PK relationship analysis for advanced regulatory justification.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical systems for precise drug measurement.
• Validation: Conducted per ICH M10, WHO TRS, and PMRA-recognized validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Statistical BE evaluation aligned with ICH and WHO harmonized standards accepted by PMRA.
• Sample Size & Power: Statistical determination for robust and reliable BE conclusions.
📑 PMRA-Ready Regulatory Documentation
We prepare full regulatory documentation suitable for submission to Malawi’s Pharmacy and Medicines Regulatory Authority (PMRA), including:
• Clinical Study Protocol (Malawi-compliant)
• Informed Consent Forms (ICF) meeting national ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for PMRA regulatory submissions
✨ Why Choose BioEquiGlobal for the Malawi Market?
• Local Regulatory Alignment: BA/BE protocols, dissolution analysis, PK evaluations, and CTD documentation customized for PMRA requirements.
• International Compliance Standards: Full adherence to GCP, GLP, WHO TRS, and ICH guidelines.
• Advanced Clinical & Analytical Capacity: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Dossier Expertise: Preparation of CTD/ACTD submissions for PMRA and global authorities including US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Malawi
Feasibility & Regulatory Assessment: Review of reference product availability, dissolution method suitability, and biowaiver eligibility.
Protocol Development: Drafting PMRA-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-based subject recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical assessment.
Documentation & Submission: Preparation of PMRA-ready CSR, dissolution profile reports, validation data, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers in Malawi seeking PMRA approval
• CROs needing BA/BE services or analytical method development
• Regulatory teams requiring PMRA-compliant CTD/ACTD dossiers