🇳🇮 Bioavailability & Bioequivalence (BA/BE) Studies Services for Nicaragua
MINSA / DRS–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides full-service Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the pharmaceutical regulatory standards of Nicaragua’s:
Ministerio de Salud (MINSA)
Dirección de Regulación Sanitaria (DRS)
All studies strictly follow MINSA/DRS guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national drug registration and regional submissions across Central America.
💊 Core Services for Nicaragua (MINSA / DRS) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BE study designs (crossover or parallel) recognized by MINSA.
• Volunteer Selection: Healthy subjects or patient groups based on therapeutic requirements.
• Ethics Approval: Required approval from a Comité Institucional de Revisión Ética (CIRE) accredited in Nicaragua.
• Protocol Development: Prepared according to ICH E6 (R2) GCP, WHO TRS, and DRS specifications.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic submissions, post-approval variations, and equivalence testing.
• Dissolution Media: Pharmacopeial & biorelevant media recognized by MINSA/DRS.
• Similarity Factor: f2 similarity factor calculation for dissolution comparison.
• Evaluation Models: WHO/ICH-compliant model-independent (f1, f2) and model-dependent approaches.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A guidelines with justification suitable for Nicaragua.
• IVIVC Modeling: Level A, B, and C models for in vitro–in vivo correlation.
• Predictive PK Modeling: Supports biowaiver justification and optimized BE study strategy.
Analytical Method Development & Validation
• Technologies: LC-MS/MS and HPLC-UV analytical platforms.
• Validation: Conducted per ICH M10, WHO TRS, and accepted validation standards compatible with MINSA.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Performed using WHO/ICH harmonized BE standards.
• Sample Size & Power: Determined scientifically to ensure conclusive BE outcomes.
📑 Nicaragua MINSA–Ready Regulatory Documentation
We prepare complete Nicaragua-specific regulatory documentation, including:
• Clinical Study Protocol (MINSA/DRS-compliant)
• Informed Consent Forms (ICF) meeting ethical guidelines in Nicaragua
• 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 submission to DRS
✨ Why Choose BioEquiGlobal for the Nicaraguan Market?
• Local Regulatory Expertise: BA/BE documentation, reports, and CTDs tailored for MINSA/DRS requirements.
• High International Standards: Fully compliant with ICH, WHO TRS, GCP, and GLP quality systems.
• Modern Clinical & Analytical Infrastructure: Accredited clinical units and high-performance analytical laboratories (including NABL-certified labs).
• Global Submission Competence: CTDs prepared for Nicaragua and major global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Nicaragua
Feasibility & Gap Assessment: Evaluation of reference product accessibility, dissolution needs, and biowaiver potential.
Protocol Development: Drafting MINSA/DRS-compliant BE protocols and obtaining CIRE approval.
Analytical Method Development: LC-MS/MS method development & validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-supervised subject recruitment, dosing, PK sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC checks, and BE statistical analysis.
Documentation & Submission: Preparation of Nicaragua-ready CSR, CDP report, validation package, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Nicaragua and Central America
• CROs requiring BE/analytical outsourcing
• Regulatory teams needing MINSA/DRS-compliant CTD/ACTD dossiers