🇪🇬 Bioavailability & Bioequivalence (BA/BE) Studies Services for Egypt

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

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to the regulatory requirements of the Egyptian Drug Authority (EDA).

All studies strictly comply with EDA Guidelines, ICH, WHO TRS, GCP, GLP, ensuring full regulatory acceptability for pharmaceutical submissions in Egypt and international markets.

💊 Core Services for Egypt (EDA) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel models accepted by EDA.
• Volunteer Selection: Healthy volunteers or patient groups depending on therapeutic class.
• Ethics Approval: Approval from an EDA-recognized Ethics Committee/IRB in accordance with national biomedical research regulations.
• Protocol Development: EDA-aligned BA/BE protocols based on ICH E6 (R2) GCP, WHO TRS, and EDA guidance.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Required for generic product registration, variations, and quality assessments.
• Dissolution Media: Pharmacopeial and biorelevant dissolution media as recommended by EDA.
• Similarity Assessment: f2 similarity factor calculation for comparing test and reference dissolution curves.
• Evaluation Methods: Model-independent (f1, f2) and model-dependent dissolution modeling.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared according to EDA’s technical requirements, WHO TRS, and ICH Q6A guidelines.
• IVIVC Modeling: Level A, B, and C models for predicting in vivo outcomes.
• Predictive PK Modeling: Supports biowaiver justification and BE study evaluations.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV systems for sensitive drug quantification.
• Validation: Conducted in accordance with ICH M10, WHO TRS, and EDA-approved validation frameworks.
• Stability Methods: Stability-indicating analytical methods for APIs and finished dosage forms.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental analysis (NCA).
• BE Statistics: Statistical evaluation aligned with ICH, WHO, and EDA BE methodology.
• Study Powering: Sample-size and power calculations based on EDA expectations for BE conclusiveness.

📑 EDA-Ready Regulatory Documentation

We prepare complete regulatory submission documents required by the Egyptian Drug Authority, including:

• Clinical Study Protocol (Egypt-compliant)
• Informed Consent Forms (ICF) aligned with Egyptian biomedical ethics regulations
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS structures
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD Modules 1–5 formatted for EDA drug registration

✨ Why Choose BioEquiGlobal for the Egyptian Market?

• EDA-Aligned Expertise: Detailed understanding of EDA expectations ensures compliant BE protocols, PK reports, and dissolution studies.
• High Quality Standards: GCP-, GLP-, WHO-, and ICH-based operations with strong internal QA processes.
• Modern Infrastructure: Accredited clinical units and advanced analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Strength: Dossier preparation for EDA and other major authorities including US FDA, EMA, MHRA, GCC, TGA, SAHPRA, and ASEAN regulators.

🗺️ BA/BE Study Workflow for Egypt

1. Feasibility & Gap Assessment: Review of Egyptian reference products, dissolution requirements, and biowaiver potential.

2. Protocol Development: Drafting EDA-compliant BA/BE protocols and assisting with Ethics Committee approval.

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

4. Clinical Execution: GCP-monitored dosing, safety evaluation, and controlled sample collection.

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

6. Documentation & Submission: Preparation of EDA-ready CSR, analytical validation reports, dissolution documentation, and CTD Modules 1–5.

Who We Support

• Egyptian pharmaceutical manufacturers seeking EDA approval
• CROs requiring analytical and BA/BE outsourcing
• Regulatory teams needing EDA-compliant CTD dossiers