🇷🇼 Bioavailability & Bioequivalence (BA/BE) Studies Services for Rwanda

Rwanda FDA / EAC-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides comprehensive Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) designed to meet the regulatory requirements of Rwanda FDA.

Our studies follow EAC Harmonized Medicines Registration Guidelines, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical manufacturers seeking product approval in Rwanda and throughout the East African Community.

💊 Core Services for Rwanda (Rwanda FDA / EAC)

1. Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose; crossover and parallel studies acceptable to Rwanda FDA.

• Volunteer Selection: Healthy volunteer recruitment under strict GCP compliance.

• Ethics Approval: Required from a recognized Rwanda Institutional Review Board (IRB) / Ethics Committee.

• Protocol Development: Prepared according to ICH E6 (R2), WHO BA/BE guidance, and EAC regulatory norms.

2. Comparative Dissolution Profiling (CDP)

• Requirement: Mandatory for generic drug submissions and formulation variations.

• Dissolution Media: Biorelevant & pharmacopoeial media compliant with WHO/EAC guidance.

• Profile Comparison: f2 similarity factor and model-based comparisons.

• Documentation: Structured for CTD Module 3 as required by Rwanda FDA.

3. IVIVC & Biowaiver Support

• BCS Biowaiver: Prepared in accordance with WHO, EAC BCS guidance, and ICH Q6A.

• IVIVC Modeling: Level A, B & C correlation.

• Predictive Performance: Evaluation of dissolution–PK relationship for regulatory justification.

4. Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV.

• Validation Standards: Fully aligned with ICH M10 and EAC analytical validation guidelines.

• Stability Methods: Stability-indicating methods for APIs and finished pharmaceutical products.

5. Pharmacokinetic (PK) & Bioequivalence Statistics

• PK Approach: Non-compartmental analysis (NCA).

• BE Statistics: CI-based BE evaluation for AUC, Cmax according to WHO/EAC criteria.

• Sample Size & Study Power: Determined using EAC-recommended statistical methodologies.

📑 Rwanda FDA–Ready Regulatory Documentation

We prepare complete, submission-ready documentation aligned with Rwanda FDA and EAC CTD formats, including:

• Clinical Study Protocol

• Informed Consent Forms (English/Kinyarwanda if required)

• Investigator’s Brochure

• Clinical Study Report (CSR) – EAC/WHO CTD format

• Bioanalytical Method Validation Report

• Comparative Dissolution Profile Report

• CTD Modules (1–5) customized for Rwanda FDA

• Required Rwanda FDA submission templates

✨ Why Choose BioEquiGlobal for Rwanda?

• Regulatory Expertise: Knowledge of Rwanda FDA rules and EAC harmonized requirements.

• Global Quality Compliance: All studies in accordance with GCP, GLP, ICH, WHO guidelines.

• Accredited Facilities: Access to validated bioanalytical labs and GCP-compliant clinical units.

• Regional Reach: Submissions supported for the entire EAC region (Rwanda, Kenya, Uganda, Tanzania, Burundi, South Sudan).

• Global Capability: Dossier preparation for FDA, EMA, MHRA, GCC, and India alongside EAC compliance.

🗺️ Our BA/BE Workflow for Rwanda

1. Feasibility & Regulatory Gap Assessment

Evaluation of reference product, biowaiver eligibility, and Rwanda FDA submission criteria.

2. Protocol Development & Ethics Review

Development of WHO/ICH-compliant protocol and securing Rwanda IRB approval.

3. Method Development & Validation

LC-MS/MS assay development and ICH M10 analytical validation.

4. Clinical Study Execution

Volunteer recruitment, dosing, blood sampling, safety monitoring under strict GCP.

5. Bioanalysis, PK & BE Assessment

PK modeling, BE statistics, QC procedures, and bioanalytical evaluation.

6. Submission-Ready Documentation

CSR preparation, CDP compilation, and CTD dossier assembly for Rwanda FDA.

Who We Support in Rwanda & East Africa

• Pharmaceutical manufacturers registering generics with Rwanda FDA

• Companies seeking multi-country EAC submissions

• CROs needing clinical or analytical BA/BE outsourcing

• Regulatory teams preparing CTD/ACTD dossiers across East Africa