🇲🇿 Bioavailability & Bioequivalence (BA/BE) Studies Services for Mozambique
ANARME-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides robust Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of Mozambique’s Autoridade Nacional Reguladora de Medicamentos (ANARME).
All studies are conducted in full compliance with ANARME guidelines, ICH, WHO TRS, GCP, and GLP, ensuring suitability for Mozambique’s pharmaceutical registration and international regulatory acceptance.
💊 Core Services for Mozambique (ANARME) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models recognized by ANARME.
• Volunteer Selection: Healthy volunteers or patient populations based on therapeutic requirements.
• Ethics Approval: Mandatory approval from a recognized Institutional Bioethics Committee/IRB in Mozambique.
• Protocol Development: ANARME-aligned BA/BE protocols developed per ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic registration, variations, and formulation equivalence assessment.
• Dissolution Media: Pharmacopeial and biorelevant media to meet ANARME expectations.
• Similarity Factor: f2 similarity factor used to compare dissolution profiles.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution modeling techniques.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and ANARME-recognized scientific standards.
• IVIVC Models: Level A, B, and C correlation models for predictive bioperformance analysis.
• Predictive PK Modeling: Supports regulatory justification for BE waivers and product optimization.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV instrumentation for accurate bioanalysis.
• Validation: Conducted as per ICH M10, WHO TRS, and ANARME-acceptable validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Methodology: Non-compartmental analysis (NCA).
• BE Statistics: Conducted according to ICH and WHO harmonized standards recognized by ANARME.
• Sample Size & Power: Statistically defined to ensure reliable BE outcomes.
📑 ANARME-Ready Regulatory Documentation
We prepare complete drug registration documentation tailored to Autoridade Nacional Reguladora de Medicamentos, including:
• Clinical Study Protocol (Mozambique-compliant)
• Informed Consent Forms (ICF) aligned with national ethics guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for ANARME submission
✨ Why Choose BioEquiGlobal for the Mozambique Market?
• Regulatory Alignment: All BE protocols, analytical validation, PK reports, and dissolution studies tailored to ANARME standards.
• High International Compliance: Operations follow GCP, GLP, WHO TRS, and ICH guidelines with strong quality assurance systems.
• Advanced Laboratory & Clinical Capacity: Accredited clinical units and modern analytical facilities (including NABL-certified labs where applicable).
• Global Submission Readiness: CTD/ACTD dossiers suitable for ANARME and global regulators such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.
🗺️ BA/BE Study Workflow for Mozambique
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution requirements, and biowaiver potential.
Protocol Development: Drafting ANARME-compliant BA/BE protocols and supporting Ethics Committee approval.
Analytical Method Development: LC-MS/MS method design and validation per ICH M10 and WHO TRS.
Clinical Execution: GCP-guided recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK analysis, QC verification, and statistical BE evaluation.
Documentation & Submission: Preparation of ANARME-ready CSR, dissolution profiles, validation data, and CTD/ACTD modules.
Who We Support
• Mozambique pharmaceutical manufacturers seeking ANARME approval
• CROs needing outsourced BA/BE or analytical services
• Regulatory teams requiring ANARME-compliant CTD/ACTD dossiers