🇦🇴 Bioavailability & Bioequivalence (BA/BE) Studies Services for Angola
ARMED-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 to the regulatory standards of ARMED — Agência Reguladora de Medicamentos e Tecnologias de Saúde, the authority responsible for drug registration in Angola.
All studies strictly follow ICH, WHO TRS, GLP, GCP, and the regulatory expectations of ARMED to support pharmaceutical submissions in Angola and international markets.
💊 Core Services for Angola (ARMED) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose and multiple-dose BE studies using crossover or parallel designs as accepted by ARMED.
• Volunteer Selection: Healthy volunteers or patients depending on therapeutic category and study requirements.
• Ethics Approval: Clearance from a recognized Ethics Committee in Angola or an internationally accredited IRB.
• Protocol Development: ARMED-aligned protocols developed as per ICH E6 (R2) GCP and WHO TRS guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generic product registration and post-approval variations in Angola.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media.
• Similarity Assessment: f2 similarity factor calculation for dissolution comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Developed following WHO TRS, ICH Q6A, and ARMED-recognized guidelines.
• IVIVC Modeling: Level A, B, and C correlation models.
• Predictive PK Analysis: In vitro–in vivo correlation to support regulatory acceptance.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted in accordance with ICH M10, WHO standards, and ARMED-acceptable validation practices.
• Stability Studies: Stability-indicating methods for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: In line with ICH and WHO harmonized BE standards recognized by ARMED.
• Study Powering: Sample-size and power calculations for conclusive BE demonstration.
📑 ARMED-Ready Regulatory Documentation
We prepare full drug registration documentation compliant with ARMED, including:
• Clinical Study Protocol (Angola-aligned)
• Informed Consent Forms (ICF) as per local ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS standards
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules formatted for Angola’s registration requirements
✨ Why Choose BioEquiGlobal for the Angolan Market?
• Regulatory Alignment: Protocols, dissolution profiles, PK analyses, and documentation tailored to ARMED’s regulatory expectations.
• High Compliance: Operations aligned with GCP, GLP, ICH, and WHO TRS with strong internal QA oversight.
• Advanced Infrastructure: Accredited clinical facilities and high-precision analytical laboratories (NABL-certified where applicable).
• Global Dossier Expertise: Preparation of CTD/ACTD dossiers for Angola and agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.
🗺️ BA/BE Study Workflow for Angola
Feasibility & Gap Assessment: Evaluation of reference product availability in Angola, dissolution method suitability, and biowaiver eligibility.
Protocol Development: Drafting ARMED-compliant BA/BE protocols and facilitating Ethics Committee approval.
Analytical Method Development: LC-MS/MS method creation and validation according to ICH M10 and WHO TRS guidelines.
Clinical Study Execution: GCP-based volunteer recruitment, dosing, and sampling.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of ARMED-ready CSR, dissolution profile reports, validation documentation, and CTD/ACTD modules.
Who We Support
• Angolan pharmaceutical manufacturers seeking ARMED approval
• CROs requiring BA/BE studies, bioanalytical services, or documentation support
• Regulatory departments needing ARMED-compliant CTD/ACTD dossiers