🇦🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Argentina
ANMAT–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides full Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with Argentina’s pharmaceutical regulatory framework under:
ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Ministerio de Salud de la Nación
All studies follow ANMAT regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring suitability for Argentina’s regulatory submissions and international market approvals.
💊 Core Services for Argentina (ANMAT) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs accepted by ANMAT.
• Volunteer Selection: Healthy adult volunteers or patient groups depending on therapeutic class.
• Ethics Approval: Required approval from a Comité de Ética en Investigación (CEI) registered with ANMAT.
• Protocol Development: Prepared per ICH E6 (R2) GCP, WHO TRS, and ANMAT BE guidelines (Disposición 3185/1999 and updates).
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for pharmaceutical equivalence, generic drug applications, and post-approval changes.
• Dissolution Media: Pharmacopeial and biorelevant media compatible with ANMAT’s standards.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Evaluation Approaches: WHO/ICH-compliant model-independent (f1, f2) and model-dependent dissolution models.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and ANMAT BCS-classification expectations.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports biowaiver justification and optimized regulatory strategy.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Per ICH M10, WHO TRS, and ANMAT-compatible validation norms.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.
Pharmacokinetic (PK) Analysis
• PK Approach: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Conducted using WHO/ICH harmonized BE methodologies.
• Sample Size & Power: Scientifically determined for reliable BE conclusions.
📑 Argentina ANMAT–Ready Regulatory Documentation
We prepare complete BA/BE regulatory documentation suitable for ANMAT submissions, including:
• Clinical Study Protocol (Argentina-compliant)
• Informed Consent Forms (ICF) per CEI/ANMAT ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for ANMAT regulatory filing
✨ Why Choose BioEquiGlobal for the Argentine Market?
• Deep Familiarity with ANMAT Regulations: Ensures BE protocols, analytical validation, and CTD dossiers meet national standards.
• Global-Standard Quality: GCP, GLP, WHO TRS, and ICH compliance supported by rigorous QA systems.
• State-of-the-Art Facilities: Accredited clinical units and modern analytical laboratories (including NABL-certified facilities).
• International Submission Expertise: CTD preparation for Argentina and global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Argentina
Feasibility & Gap Assessment: Reference product review, dissolution comparison, and biowaiver eligibility assessment.
Protocol Development: Creation of ANMAT-compliant BA/BE protocols and coordination of CEI ethics approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & WHO TRS.
Clinical Execution: GCP-supervised subject recruitment, dosing, sampling, and medical safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical assessment.
Documentation & Submission: Preparation of ANMAT-ready CSR, CDP report, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical companies targeting Argentina and Latin American markets
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing ANMAT-compliant CTD/ACTD dossiers