🇻🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Venezuela

SACS / MPPS–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 tailored to the pharmaceutical regulatory requirements of Venezuela’s:

• SACS – Servicio Autónomo de Contraloría Sanitaria

• Ministerio del Poder Popular para la Salud (MPPS)

All studies strictly follow SACS regulations, ICH guidelines, WHO TRS, GCP, and GLP, ensuring readiness for national submissions and regional Latin American approvals.

💊 Core Services for Venezuela (SACS / MPPS) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BE studies in crossover or parallel formats accepted by SACS.
• Volunteer Selection: Healthy adult volunteers or specific patient groups depending on therapeutic indication.
• Ethics Approval: Required approval from a Comité de Bioética / Comité de Ética en Investigación (CEI) accredited in Venezuela.
• Protocol Development: Developed according to ICH E6 (R2) GCP, WHO TRS standards, and SACS regulatory requirements.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Mandatory for generic applications, reformulations, and pharmaceutical equivalence evaluations.
• Dissolution Media: Pharmacopeial & biorelevant media recognized by SACS.
• Similarity Factor: f2 similarity factor for comparing dissolution curves.
• Evaluation Approaches: WHO/ICH-aligned model-independent (f1, f2) and model-dependent methods.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to WHO TRS, ICH Q6A, and SACS acceptance criteria.
• IVIVC Modeling: Level A, B, and C in vitro–in vivo correlation models.
• Predictive PK Modeling: Supports regulatory strategy and biowaiver justification.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems.
• Validation: Per ICH M10, WHO TRS, and Venezuelan regulatory expectations.
• Stability-Indicating Methods: Developed for APIs and finished dosage forms.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using WHO/ICH harmonized statistical approaches.
• Sample Size & Power: Scientifically determined to ensure robust BE conclusions.

📑 Venezuela SACS–Ready Regulatory Documentation

We prepare full regulatory documentation tailored for pharmaceutical submissions to SACS/MPPS, including:

• Clinical Study Protocol (Venezuela-compliant)
• Informed Consent Forms (ICF) meeting CEI ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) per WHO TRS & ICH standards
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) structured for submission to SACS

✨ Why Choose BioEquiGlobal for the Venezuelan Market?

• Regulatory Expertise: Deep understanding of SACS requirements for pharmaceuticals and generics.
• Strict Global Compliance: GCP, GLP, WHO TRS, and ICH adherence backed by robust quality assurance systems.
• Advanced Infrastructure: Accredited clinical units and modern analytical laboratories (including NABL-certified facilities).
• Regional & Global Regulatory Capability: CTDs for Venezuela and major international agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Venezuela

1. Feasibility & Gap Assessment: Evaluation of reference drug availability, dissolution requirements, and biowaiver feasibility.

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

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

4. Clinical Study Execution: GCP-supervised dosing, PK sampling, participant monitoring, and safety oversight.

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

6. Documentation & Submission: Prepare SACS-ready CSR, CDP report, validation package, and CTD/ACTD modules.

Who We Support

• Pharmaceutical manufacturers targeting Venezuela and Latin America
• CROs requiring BA/BE outsourcing or analytical method development
• Regulatory teams needing SACS/MPPS–compliant CTD/ACTD dossiers