🇨🇺 Bioavailability & Bioequivalence (BA/BE) Studies Services for Cuba

CECMED–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 aligned with Cuba’s regulatory framework under:

• CECMED – Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos

• Ministerio de Salud Pública (MINSAP)

All studies follow CECMED regulations, WHO TRS, ICH guidelines, GCP, and GLP, ensuring readiness for pharmaceutical submissions in Cuba and international markets.

💊 Core Services for Cuba (CECMED / MINSAP) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose crossover or parallel BE study designs accepted by CECMED.
• Volunteer Selection: Healthy volunteers or patient-specific cohorts when required.
• Ethics Approval: Mandatory approval from a Comité de Ética de la Investigación (CEI) recognized by MINSAP.
• Protocol Development: Prepared in accordance with ICH E6 (R2) GCP, WHO TRS, and CECMED guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic submissions, formulation modifications, and equivalence demonstrations.
• Dissolution Media: Pharmacopeial and biorelevant media allowed by CECMED.
• Similarity Factor: f2 similarity factor for dissolution profile comparison.
• Modeling Approaches: Model-independent (f1, f2) and model-dependent dissolution analysis per WHO/ICH practices.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS and ICH Q6A guidelines, compatible with CECMED review expectations.
• IVIVC Models: Level A, B, and C correlation models for improved predictability.
• Predictive PK Modeling: Used to support biowaiver requests and BE risk assessment.

Analytical Method Development & Validation

• Instrumentation: LC-MS/MS and HPLC-UV systems for sensitive and accurate quantification.
• Validation: Conducted per ICH M10, WHO TRS, and CECMED-recognized analytical validation standards.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• Methodology: Non-compartmental PK analysis (NCA).
• BE Statistics: Performed using WHO/ICH harmonized BE evaluation procedures.
• Sample Size & Power: Determined scientifically to ensure statistically reliable BE conclusions.

📑 Cuba CECMED–Ready Regulatory Documentation

We prepare complete regulatory documents tailored for Cuba’s pharmaceutical regulatory system, including:

• Clinical Study Protocol (CECMED-compliant)
• Informed Consent Forms (ICF) meeting Cuban ethical standards
• Investigator Brochure
• Clinical Study Report (CSR) based on ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for CECMED submissions

✨ Why Choose BioEquiGlobal for the Cuban Market?

• Expertise in CECMED Regulations: All protocols, reports, and CTDs tailored to Cuba’s national regulatory expectations.
• Strict Global Compliance: GCP, GLP, WHO TRS, and ICH adherence with comprehensive QA oversight.
• Advanced Analytical & Clinical Infrastructure: Accredited clinical units and high-performance analytical laboratories (including NABL-certified facilities).
• Global Submission Capability: CTDs prepared for Cuba and major regulatory authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Cuba

1. Feasibility & Gap Assessment: Review of reference product availability, dissolution comparability, and biowaiver feasibility.

2. Protocol Development: Drafting CECMED-compliant BA/BE protocols and securing CEI ethics approval.

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

4. Clinical Study Execution: GCP-supervised recruitment, dosing, sample collection, and medical monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE assessment.

6. Documentation & Submission: Preparation of Cuba-ready CSR, CDP report, validation documents, and CTD/ACTD modules.

Who We Support

• Pharmaceutical manufacturers targeting the Cuban market
• CROs requiring BA/BE or analytical outsourcing
• Regulatory teams needing CECMED-compliant CTD/ACTD dossiers