🇬🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Guatemala
DRCPFA / MSPAS–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling aligned with the regulatory standards of Guatemala’s:
Dirección de Regulación, Control y Vigilancia de Productos Farmacéuticos y Afines (DRCPFA)
Ministerio de Salud Pública y Asistencia Social (MSPAS)
All studies follow Guatemalan regulatory guidelines, ICH standards, WHO TRS, GCP, and GLP, ensuring suitability for national pharmaceutical registration and regional submissions across Central America.
💊 Core Services for Guatemala (DRCPFA / MSPAS) Regulatory Submissions
Clinical BA/BE Studies (Human)
• Study Designs: Single-dose & multiple-dose BE studies (crossover or parallel) accepted by DRCPFA.
• Volunteer Selection: Healthy adult volunteers or patient groups when therapeutically necessary.
• Ethics Approval: Required approval from a Comité de Ética en Investigación (CEI) recognized by MSPAS.
• Protocol Development: Prepared according to ICH E6 (R2) GCP, WHO TRS, and DRCPFA requirements.
Comparative Dissolution Profiling (CDP)
• Regulatory Requirement: Required for generic submissions, formulation variations, and equivalence evaluation.
• Dissolution Media: Pharmacopeial and biorelevant media suitable for DRCPFA review.
• Similarity Factor: f2 similarity factor calculation for dissolution equivalence.
• Evaluation Models: Model-independent (f1, f2) and model-dependent analysis per WHO/ICH standards.
IVIVC & Biowaiver Support
• BCS-Based Biowaiver: Prepared per WHO TRS and ICH Q6A guidelines with justification suitable for DRCPFA.
• IVIVC Modeling: Level A, B, and C correlation modeling.
• Predictive PK Modeling: Used to support biowaiver applications and regulatory strategy optimization.
Analytical Method Development & Validation
• Analytical Platforms: LC-MS/MS and HPLC-UV for sensitive and accurate quantification.
• Validation: Conducted per ICH M10, WHO TRS, and standards compatible with DRCPFA expectations.
• Stability-Indicating Methods: Developed for APIs and finished products.
Pharmacokinetic (PK) Analysis
• PK Method: Non-compartmental analysis (NCA).
• BE Statistical Evaluation: Performed using WHO/ICH harmonized BE procedures.
• Sample Size & Power: Determined scientifically for reliable BE outcomes.
📑 Guatemala DRCPFA–Ready Regulatory Documentation
We prepare complete regulatory documentation tailored for Guatemala’s MSPAS/DRCPFA, including:
• Clinical Study Protocol (Guatemala-compliant)
• Informed Consent Forms (ICF) meeting CEI 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 DRCPFA submission
✨ Why Choose BioEquiGlobal for the Guatemalan Market?
• Local Regulatory Expertise: All protocols, validation documents, PK reports, and CTD modules tailored to DRCPFA requirements.
• High International Quality Standards: GCP, GLP, WHO TRS, and ICH compliance with strong internal QA systems.
• Advanced Clinical & Analytical Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified facilities).
• Global Submission Capability: CTD dossiers for Guatemala and major international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).
🗺️ BA/BE Study Workflow for Guatemala
Feasibility & Gap Assessment: Reference product review, dissolution compatibility, and biowaiver potential.
Protocol Development: Drafting DRCPFA-compliant protocols and securing CEI ethics approval.
Analytical Method Development: LC-MS/MS validation per ICH M10 & WHO TRS.
Clinical Study Execution: GCP-driven volunteer recruitment, dosing, PK sampling, and safety monitoring.
Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistical analysis.
Documentation & Submission: Preparation of Guatemala-ready CSR, dissolution report, validation documentation, and CTD/ACTD modules.
Who We Support
• Pharmaceutical manufacturers targeting Guatemala or Central American markets
• CROs seeking BA/BE or analytical outsourcing
• Regulatory teams needing DRCPFA-compliant CTD/ACTD dossiers