🇧🇮 Bioavailability & Bioequivalence (BA/BE) Studies Services for Burundi

ABREMA/EAC-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., delivers complete Bioavailability/Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) tailored for the regulatory framework of Burundi’s National Medicines & Food Regulatory Authority (ABREMA).

Our studies follow EAC Harmonized Technical Guidelines, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical manufacturers seeking product registration in Burundi and across the East African Community.

💊 Core Services for Burundi (ABREMA/EAC) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Types: Single-dose or multiple-dose; crossover & parallel designs required by EAC BA/BE guidance.

• Volunteer Selection: Healthy volunteers recruited in line with international GCP standards.

• Ethics Approval: Mandatory approval from a Burundi-recognized Ethics Committee or an accredited regional IRB.

• Protocol Standards: Developed according to EAC BA/BE guidelines, ICH E6 (R2), and ABREMA submission expectations.

Comparative Dissolution Profiling (CDP)

• Regulatory Need: Required for generic drug submissions, formulation updates, and variations.

• Dissolution Media: Biorelevant and standard pharmacopoeial media aligned with EAC recommendations.

• Similarity Evaluation: f2 similarity factor, model-dependent and model-independent assessments.

• Reporting: CDP prepared per EAC Common Technical Document (CTD) structure.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Developed according to WHO, ICH Q6A, and EAC harmonized BCS guidance.

• IVIVC Modeling: Level A, B, and C IVIVC models.

• Predictive Performance: PK–dissolution link evaluation suitable for justification in ABREMA reviews.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV systems for robust bioanalysis.

• Validation: As per ICH M10 and EAC analytical validation principles.

• Stability Indicating Methods: For both APIs and finished products, suitable for EAC dossier submission.

Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Analysis: Non-compartmental analysis (NCA) using validated tools.

• BE Statistics: ANOVA, confidence-interval evaluation, and statistical methods accepted by EAC.

• Sample Size: Based on variability and BE power calculations per EAC guidance.

📑 Burundi (ABREMA) / EAC-Ready Regulatory Documentation

We prepare a complete documentation package compatible with Burundi’s ABREMA and the EAC Harmonized Medicines Registration system.

Includes:

• Clinical Study Protocol

• Informed Consent Forms (Kirundi/French/English if required)

• Investigator’s Brochure

• Clinical Study Report (CSR) as per EAC CTD format

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• EAC/CTD Modules 1–5 formatted for ABREMA submission

• Supplementary ABREMA application forms for generics

✨ Why Choose BioEquiGlobal for Burundi?

• Regulatory Expertise: Familiarity with ABREMA, EAC Harmonized Guidelines, and regional submission expectations.

• Global Standards: Operations under GCP, GLP, ICH, and WHO frameworks.

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

• Regional Reach: Ability to prepare multi-country EAC dossiers covering Burundi, Kenya, Tanzania, Uganda, Rwanda, and South Sudan.

• International Support: Dossier readiness for EMA, US FDA, GCC, India, and other markets.

🗺️ Our BA/BE Workflow for Burundi

1. Feasibility & EAC Gap Assessment

Evaluation of reference product suitability, regulatory pathway, and dossier requirements for ABREMA/EAC.

2. Protocol Development & Ethics Approval

Development of EAC-aligned protocols and obtaining ethics clearance from Burundi or EAC-authorized committees.

3. Analytical Method Development

LC-MS/MS method creation and ICH M10 validation.

4. Clinical Study Execution

Recruitment, dosing, sample handling, and safety monitoring under ICH-GCP compliance.

5. Bioanalysis, PK & BE Evaluation

Full bioanalytical testing, PK computation, and BE statistical evaluation.

6. Documentation & Submission Package

CSR preparation, CDP reporting, and CTD dossier assembly for submission to ABREMA.

Who We Support in Burundi & East Africa

• Pharmaceutical manufacturers seeking product registration in Burundi.

• Companies planning EAC region-wide submissions.

• CROs requiring analytical or clinical outsourcing.

• Regulatory teams assembling CTD/ACTD dossiers for East African countries.