🇪🇨 Bioavailability & Bioequivalence (BA/BE) Studies Services for Ecuador
ARCSA–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, delivers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Ecuador’s pharmaceutical regulatory standards under:
ARCSA – Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
Ministerio de Salud Pública (MSP)
All studies comply with ARCSA’s regulatory framework, ICH guidelines, WHO TRS, GCP, and GLP, ensuring suitability for Ecuadorian drug registration and regional Latin American approvals.
💊 Core Services for Ecuador (ARCSA / MSP) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: ARCSA-accepted single-dose & multiple-dose BE study designs in crossover or parallel formats.
• Volunteer Selection: Healthy adults or patient groups when required by the therapeutic indication.
• Ethics Approval: Mandatory approval from an ECU Institutional Bioethics Committee (Comité de Ética en Investigación, CEI) accredited by MSP.
• Protocol Development: Developed according to ICH E6 (R2) GCP, WHO TRS, and ARCSA methodological guidelines.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for generics, variations, line extensions, and pharmaceutical equivalence assessments.
• Dissolution Media: Pharmacopeial and biorelevant media recognized by ARCSA.
• Similarity Factor: f2 similarity factor calculation for dissolution curve comparison.
• Evaluation Models: WHO/ICH-compliant model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared following WHO TRS, ICH Q6A, and ARCSA scientific acceptance criteria.
• IVIVC Models: Level A, B, and C correlation models for regulatory predictability.
• Predictive PK Modeling: Helps justify biowaiver submissions and refine BE study strategies.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV systems for precise quantification.
• Validation: Per ICH M10, WHO TRS, and standards aligned with ARCSA expectations.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using WHO/ICH harmonized statistical tools.
• Sample Size & Power: Scientifically justified to ensure conclusive BE outcomes.
📑 Ecuador ARCSA–Ready Regulatory Documentation
We develop complete regulatory documentation tailored for ARCSA submissions, including:
• Clinical Study Protocol (Ecuador-compliant)
• Informed Consent Forms (ICF) per CEI/MSP ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for ARCSA regulatory filing
✨ Why Choose BioEquiGlobal for the Ecuadorian Market?
• Deep Understanding of ARCSA Standards: Ensures BE protocols, dissolution studies, analytical validations, and CTDs align with local requirements.
• Top-Level Compliance: GCP, GLP, WHO TRS, and ICH standards enforced through strong quality assurance systems.
• Advanced Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified labs).
• Global Submission Readiness: CTDs prepared for Ecuador and major global regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Ecuador
Feasibility & Gap Assessment: Evaluation of innovator product, dissolution comparability, and biowaiver feasibility.
Protocol Development: Drafting ARCSA-compliant BA/BE protocols and coordinating CEI ethics approval.
Analytical Method Development: LC-MS/MS method validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised participant dosing, PK sampling, safety monitoring, and data collection.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.
Documentation & Submission: Preparation of ARCSA-ready CSR, CDP report, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Ecuador and the Andean Region
• CROs needing BA/BE outsourcing or analytical development
• Regulatory teams requiring ARCSA-compliant CTD/ACTD dossiers