🇦🇷 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 – AdministraciĂłn Nacional de Medicamentos, Alimentos y TecnologĂa MĂ©dica
Ministerio de Salud de la NaciĂłn
All studies follow ANMAT regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring suitability for Argentina’s regulatory submissions and international market approvals.
đź’Š 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