🇭🇹 Bioavailability & Bioequivalence (BA/BE) Studies Services for Haiti

DPM/MT – MSPP–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 tailored to Haiti’s pharmaceutical regulatory requirements under:

• Ministère de la Santé Publique et de la Population (MSPP)

• Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (DPM/MT)

All studies comply with DPM/MT standards, ICH guidelines, WHO TRS, GCP, and GLP, supporting regulatory approval for Haiti and international markets.

💊 Core Services for Haiti (MSPP / DPM/MT) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BE studies using crossover or parallel models recognized by DPM/MT.
• Volunteer Selection: Healthy adult volunteers or relevant patient cohorts based on therapeutic class.
• Ethics Approval: Mandatory approval from a Comité National de Bioéthique (CNB) or institutional ethics committee.
• Protocol Development: Prepared according to ICH E6 (R2) GCP, WHO TRS, and Haiti’s regulatory guidelines.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Needed for generic submissions, formulation variations, and equivalence evaluations.
• Dissolution Media: Pharmacopeial & biorelevant media recognized by DPM/MT.
• Similarity Factor: f2 similarity factor calculation to compare dissolution curves.
• Evaluation Approaches: Includes model-independent (f1, f2) and model-dependent methods aligned with WHO/ICH expectations.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared per WHO TRS and ICH Q6A, with justification tailored for DPM/MT review.
• IVIVC Modeling: Level A, B, or C models for in vitro–in vivo correlation.
• Predictive PK Modeling: Used to support biowaiver applications and BE strategy refinement.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV instrumentation.
• Validation: Conducted in accordance with ICH M10, WHO TRS, and Haiti-compatible validation norms.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical formulations.

Pharmacokinetic (PK) Analysis

• PK Method: Non-compartmental analysis (NCA).
• BE Statistics: Conducted using ICH and WHO harmonized statistical standards.
• Sample Size & Power: Scientifically justified to ensure conclusive BE outcomes.

📑 Haiti DPM/MT–Ready Regulatory Documentation

We prepare complete regulatory packages tailored for submission to MSPP / DPM/MT, including:

• Clinical Study Protocol (Haiti-compliant)
• Informed Consent Forms (ICF) aligned with Haiti’s ethical guidelines
• Investigator Brochure
• Clinical Study Report (CSR) per ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) designed for Haitian pharmaceutical submissions

✨ Why Choose BioEquiGlobal for the Haitian Market?

• Local Regulatory Understanding: Expertise in MSPP/DPM/MT requirements for generics and pharmaceutical registrations.
• Full Compliance: Adherence to GCP, GLP, WHO TRS, and ICH guidelines, supported by strong QA systems.
• Advanced Infrastructure: Accredited clinical research units and modern analytical laboratories (including NABL-certified facilities).
• Global Regulatory Reach: CTDs prepared for Haiti and major international authorities (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Haiti

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

2. Protocol Development: Drafting Haiti/DPM/MT–compliant BA/BE protocols and facilitating CNB ethics approval.

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

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

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

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

Who We Support

• Pharmaceutical manufacturers targeting Haiti
• CROs requiring BA/BE outsourcing or analytical services
• Regulatory teams needing DPM/MT-compliant CTD/ACTD dossiers