🇧🇯 Bioavailability & Bioequivalence (BA/BE) Studies Services for Benin

ANSM-Benin / ECOWAS-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) tailored specifically to the regulatory framework of Benin’s National Agency for Food and Drug Control (ANSM-Benin).

Our studies comply with ECOWAS Harmonized Guidelines, ICH, WHO TRS, GCP, and GLP—supporting pharmaceutical companies seeking drug approvals for Benin and the broader West African Region.

💊 Core Services for Benin (ANSM-Benin/ECOWAS) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose, crossover or parallel designs per ECOWAS BA/BE guidance.

• Volunteer Selection: Healthy volunteer studies performed under international GCP requirements.

• Ethics Approval: Mandatory approval from a recognized Ethics Committee in accordance with Benin’s national bioethics laws.

• Protocol Development: Developed under ECOWAS BA/BE standards, ICH E6 (R2), and Benin’s regulatory expectations.

Comparative Dissolution Profiling (CDP)

• Requirement: Needed for generic drugs, post-approval variations, and formulation comparisons per ECOWAS guidelines.

• Media Selection: Biorelevant & standard pharmacopoeial dissolution media.

• Similarity Metrics: f2 similarity factor, model-dependent and model-independent kinetic modeling.

• Report Format: Fully aligned with ECOWAS registration dossier requirements.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to ECOWAS BCS guidance, WHO, and ICH Q6A.

• IVIVC Modeling: Level A, B, and C IVIVC models for extended-release or BCS-appropriate drugs.

• Predictive Tools: In vitro–in vivo modeling to support waivers or BE justification.

Analytical Method Development & Validation

• Technology Platforms: LC-MS/MS and HPLC-UV platforms for robust quantification.

• Validation Standards: Fully compliant with ICH M10 and ECOWAS analytical validation requirements.

• Stability Studies: API and formulation stability-indicating method development.

Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Analysis: Non-compartmental PK calculations (NCA).

• BE Statistical Methods: ECOWAS-compatible confidence interval approach for Cmax, AUC, and key parameters.

• Sample Size Estimation: Power-based analysis aligned with ECOWAS standards.

📑 Benin (ANSM-Benin) / ECOWAS-Ready Regulatory Documentation

We prepare complete, submission-ready documentation for ANSM-Benin and ECOWAS Harmonized Registration.

Includes:

• Clinical Study Protocol

• Informed Consent Forms (French & English if required)

• Investigator’s Brochure

• Clinical Study Report (CSR) structured for ECOWAS

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD/ACTD Modules tailored for ECOWAS and ANSM-Benin

• Supplemental regulatory forms required for generic drug applications

✨ Why Choose BioEquiGlobal for the Benin Market?

• Regulatory Alignment: Expertise in ANSM-Benin processes and the ECOWAS Harmonized Medicines Registration System.

• Global Quality Compliance: All clinical and analytical operations follow GCP, GLP, ICH, and WHO guidelines.

• Accredited Infrastructure: Access to validated analytical labs and certified clinical units.

• Pan-African & Global Reach: Capability to prepare dossiers for Benin, ECOWAS, East Africa, Middle East, EU, US, and other markets.

🗺️ Our BA/BE Workflow for Benin

1. Feasibility & ECOWAS Gap Assessment

Evaluation of reference product suitability, BCS class, and Benin/ECOWAS requirements.

2. Protocol Development & Ethics Approval

Preparation of ECOWAS-aligned protocols and securing approval from recognized Ethics Committees.

3. Analytical Method Development

Development & ICH M10-compliant validation of LC-MS/MS methods.

4. Clinical Study Execution

Volunteer enrollment, dosing, sampling, and safety monitoring under GCP principles.

5. Bioanalysis, PK & BE Evaluation

Bioanalytical testing, PK calculation, statistical BE assessment.

6. Documentation & Submission

CSR development, dissolution reporting, and CTD/ECOWAS dossier preparation for ANSM-Benin submission.

Who We Support in Benin & West Africa

• Pharmaceutical manufacturers registering generic products in Benin.

• Companies targeting ECOWAS multi-country approvals.

• CROs outsourcing clinical or analytical BA/BE components.

• Regulatory teams preparing CTD/ACTD dossiers for West African agencies.