🇨🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Costa Rica

DRPIS / Ministry of Health–Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling designed to meet the regulatory expectations of Costa Rica’s:

• Ministerio de Salud (Ministry of Health)

• Dirección de Regulación de Productos de Interés Sanitario (DRPIS)

All studies strictly follow Costa Rican regulatory requirements, ICH guidelines, WHO TRS, GCP, and GLP, ensuring suitability for national submissions and regional approvals across Central America.

💊 Core Services for Costa Rica (DRPIS) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BE studies in crossover or parallel formats.
• Volunteer Selection: Healthy subjects or patient groups depending on therapeutic class.
• Ethics Approval: Required approval by a recognized Comité Ético Científico (CEC) in Costa Rica.
• Protocol Development: Prepared according to ICH E6 (R2) GCP, WHO TRS, and DRPIS requirements.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic submissions, post-approval variations, and pharmaceutical equivalence testing.
• Dissolution Media: Pharmacopeial & biorelevant media per DRPIS and WHO guidelines.
• Similarity Factor: f2 similarity factor for dissolution comparison.
• Evaluation Approaches: Model-independent (f1, f2) and model-dependent dissolution comparisons.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A, in line with Costa Rican regulatory acceptance.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports scientific justification for biowaiver and regulatory optimization.

Analytical Method Development & Validation

• Analytical Technologies: LC-MS/MS and HPLC-UV methods for drug quantification.
• Validation: Conducted per ICH M10, WHO TRS, and Costa Rica–recognized validation standards.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.

Pharmacokinetic (PK) Analysis

• Approach: Non-compartmental PK analysis (NCA).
• Statistical BE Evaluation: Conducted using ICH/WHO harmonized criteria.
• Study Power & Sample Size: Scientifically designed to meet DRPIS expectations.

📑 Costa Rica DRPIS–Ready Regulatory Documentation

We prepare complete regulatory documentation tailored for DRPIS submission, including:

• Clinical Study Protocol (Costa Rica–compliant)
• Informed Consent Forms (ICF) meeting CEC requirements
• 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 Ministry of Health submissions

✨ Why Choose BioEquiGlobal for the Costa Rican Market?

• Regulatory Expertise: Knowledge of DRPIS requirements for pharmaceuticals and generics.
• High International Quality Standards: Compliance with GCP, GLP, WHO TRS, and ICH with robust QA systems.
• Advanced Research Facilities: Accredited clinical units and modern analytical labs (including NABL-certified facilities).
• Global Regulatory Reach: CTDs prepared for Costa Rica and global regulators (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Costa Rica

1. Feasibility & Gap Assessment: Reference product evaluation, dissolution comparison, and biowaiver feasibility.

2. Protocol Development: Drafting DRPIS-compliant BA/BE protocols and obtaining ethical approval from a CEC.

3. Analytical Method Development: LC-MS/MS validation per ICH M10 & WHO TRS.

4. Clinical Execution: GCP-compliant recruitment, dosing, and PK sampling with safety monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC verification, and BE statistics.

6. Documentation & Submission: Preparation of DRPIS-ready CSR, dissolution profile, validation reports, and CTD/ACTD modules.

Who We Support

• Pharmaceutical companies targeting Costa Rica or Central American markets
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing DRPIS-compliant CTD/ACTD dossiers