Byet El Khebra (Byet El Khebra El Dwaea) is a leading pharmaceutical regulatory affairs consultancy headquartered in Egypt, providing comprehensive regulatory, scientific, compliance, and market access solutions for pharmaceutical companies, biotechnology organizations, medical device manufacturers, healthcare innovators, and market authorization holders across Egypt, the GCC, and the wider MENA region.
With more than 20 years of regulatory expertise, over 500 successfully registered healthcare products, and an ISO 9001:2015 certified quality management system, Byet El Khebra has established itself as a trusted authority in pharmaceutical regulatory affairs, drug registration, CTD dossier preparation, eCTD publishing, medical device registration, biosimilars regulatory projects, pharmacovigilance, quality compliance, and regulatory consulting.
Our mission is to advance healthcare innovation through regulatory excellence, scientific integrity, compliance leadership, and evidence-based decision-making that accelerate market access and support sustainable business growth.
Byet El Khebra was founded to bridge the gap between healthcare innovation and regulatory compliance.
We combine regulatory science, strategic planning, quality management principles, compliance excellence, and practical industry expertise to help healthcare organizations navigate increasingly complex regulatory environments.
Our multidisciplinary expertise enables pharmaceutical, biotechnology, medical device, and healthcare companies to achieve successful product approvals, maintain regulatory compliance, and optimize product lifecycle management across regulated markets.
We support organizations operating in pharmaceuticals, biologics, biosimilars, medical devices, in vitro diagnostics (IVDs), cosmetics, food supplements, disinfectants, and healthcare products throughout Egypt and the MENA region.
Comprehensive regulatory support across the full healthcare product lifecycle:
Byet El Khebra operates under the leadership of Dr. Asmaa Hussien, pharmaceutical regulatory affairs expert, regulatory science researcher, industry consultant, and developer of the Regulatory Science Framework™.
The Regulatory Science Framework™ is a structured methodology designed to integrate scientific evaluation, regulatory strategy, quality systems, pharmacovigilance, compliance management, risk assessment, and lifecycle planning into a unified decision-making model.
This framework enables healthcare organizations to improve regulatory performance, strengthen compliance effectiveness, reduce approval risks, and accelerate patient access to innovative healthcare products.
Through more than two decades of professional experience, Dr. Asmaa Hussien has contributed to the successful registration, compliance management, and lifecycle support of hundreds of healthcare products across multiple therapeutic and regulatory categories.
What is pharmaceutical regulatory affairs? Pharmaceutical regulatory affairs is the discipline responsible for ensuring healthcare products comply with applicable regulations throughout their development, approval, and post-marketing lifecycle.
What is drug registration in Egypt? Drug registration is the regulatory process required to obtain approval from the Egyptian Drug Authority (EDA) before a pharmaceutical product can be marketed and distributed in Egypt.
What is CTD dossier preparation? CTD dossier preparation involves compiling quality, non-clinical, and clinical information into the internationally recognized Common Technical Document format used for regulatory submissions.
What is eCTD publishing? eCTD publishing is the preparation, validation, management, and electronic submission of regulatory dossiers according to international electronic submission standards.
Do you provide medical device registration services? Yes. Byet El Khebra supports medical device and IVD manufacturers with regulatory strategy, technical documentation, registration, and compliance activities.
Do you support biosimilars registration? Yes. We provide specialized regulatory support for biosimilars including regulatory strategy, comparative assessments, submissions, and lifecycle management.
Do you provide pharmacovigilance services? Yes. Our pharmacovigilance services include safety system establishment, risk management, compliance support, safety reporting, and inspection readiness.
To become the most trusted pharmaceutical regulatory affairs and regulatory science authority in Egypt and the MENA region by advancing regulatory excellence, scientific innovation, compliance leadership, and patient-focused healthcare solutions.
Whether you need support with drug registration, CTD dossier preparation, eCTD publishing, medical device registration, biosimilars regulatory projects, pharmacovigilance, quality compliance, or regulatory consulting, our experts are ready to support your success.
Start the conversation in one of three ways: