🇺🇾 Bioavailability & Bioequivalence (BA/BE) Studies Services for Uruguay
MSP / DAME–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, offers comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory standards of Uruguay’s:
Ministerio de Salud Pública (MSP)
Departamento de Medicamentos (DAME)
División Evaluación Sanitaria (DESA)
All studies strictly follow MSP/DAME regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring compliance for Uruguay’s pharmaceutical submissions and broader Latin American approvals.
💊 Core Services for Uruguay (MSP / DAME) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose crossover or parallel BE designs accepted by MSP/DAME.
• Volunteer Selection: Healthy volunteers or patient cohorts depending on therapeutic class.
• Ethics Approval: Mandatory approval from a Comité de Ética en Investigación (CEI) accredited in Uruguay.
• Protocol Development: Prepared per ICH E6 (R2) GCP, WHO TRS, and MSP/DAME technical requirements.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Essential for pharmaceutical equivalence evaluation, generics, and post-registration variations.
• Dissolution Media: Pharmacopeial and biorelevant media accepted by MSP/DAME.
• Similarity Factor: f2 similarity factor for dissolution curve comparison.
• Evaluation Approaches: WHO/ICH-recognized model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and MSP biowaiver guidelines.
• IVIVC Models: Level A, B, and C modeling for strong in vitro–in vivo correlation.
• Predictive PK Modeling: Enhances regulatory justification for biowaiver requests.
Analytical Method Development & Validation
• Platforms: LC-MS/MS and HPLC-UV analytical technologies.
• Validation: Conducted as per ICH M10, WHO TRS, and MSP-compatible validation norms.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using WHO/ICH harmonized BE standards.
• Sample Size & Power: Scientifically calculated for robust BE outcomes.
📑 Uruguay MSP–Ready Regulatory Documentation
We prepare complete regulatory files tailored to Uruguay’s pharmaceutical submission requirements, including:
• Clinical Study Protocol (Uruguay-compliant)
• Informed Consent Forms (ICF) meeting CEI ethical norms
• Investigator Brochure
• Clinical Study Report (CSR) following WHO TRS & ICH format
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) structured for MSP/DAME submission
✨ Why Choose BioEquiGlobal for the Uruguayan Market?
• Expert Knowledge of MSP/DAME: BE protocols, dissolution studies, and CTDs designed specifically for Uruguay’s regulatory expectations.
• Global-Standard Quality: GCP, GLP, WHO TRS, and ICH compliance supported by stringent QA systems.
• Advanced Technical Infrastructure: High-performance analytical labs (including NABL-certified) and accredited clinical research facilities.
• Regional & Global Capacity: CTDs prepared for Uruguay and major international regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Uruguay
Feasibility & Gap Assessment: Evaluation of reference product availability, dissolution comparisons, and eligibility for biowaiver.
Protocol Development: Creation of MSP-compliant BA/BE protocols and coordination of CEI ethics approval.
Analytical Method Development: LC-MS/MS validation in accordance with ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised participant recruitment, dosing, sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE assessment.
Documentation & Submission: Delivery of MSP-ready CSR, CDP report, validation documents, and CTD/ACTD modules.
Who We Support
• Pharmaceutical companies targeting Uruguay and the MERCOSUR region
• CROs requiring analytical or BA/BE outsourcing
• Regulatory teams needing MSP/DAME–compliant CTD/ACTD dossiers