About Us
About Us
Bayt El Khebra El Dwaea Pharmaceutical Consulting
Bayt El Khebra El Dwaea Pharmaceutical Consulting is a specialized pharmaceutical regulatory advisory firm founded by Dr. Asmaa Hussein, supporting pharmaceutical companies with regulatory decision-making, market entry strategy, and compliant regulatory execution across Egypt and the Gulf Cooperation Council (GCC).
We work as a strategic regulatory partner, helping companies navigate complex regulatory environments and make informed regulatory decisions before committing time, cost, and resources to execution.
Our focus is on regulatory clarity, readiness, and long-term compliance, enabling sustainable market access rather than short-term approvals.
Focus Areas
- Pharmaceutical Regulatory Consulting
- Regulatory Affairs & decision support
- Drug Registration Strategy
- Market Entry Strategy
- eCTD / EXTEDO implementation support
- Egypt & GCC regulatory expertise
Our Role
Our role extends beyond regulatory documentation, submissions, or technical file preparation.
We support pharmaceutical companies at critical regulatory decision points, ensuring that each regulatory pathway is aligned with:
- Regulatory authority expectations
- Market realities
- Business and compliance objectives
By focusing on regulatory feasibility and risk assessment before execution, we help companies avoid costly delays, misaligned strategies, and regulatory uncertainty.
Our Expertise
With extensive hands-on experience in Regulatory Affairs, Drug Registration Strategy, and Pharmaceutical Market Entry, our expertise includes:
- Regulatory assessment and decision-making
- Pharmaceutical market entry strategy
- Biologics and biosimilars regulatory advisory
- eCTD readiness, publishing strategy, and lifecycle management (EXTEDO)
- Regulatory execution oversight aligned with authority requirements
Our work is grounded in a deep understanding of regulatory frameworks within Egypt and GCC markets, supported by a regional perspective on regulatory compliance and execution.
Our Approach
We believe that regulatory affairs is not a purely administrative function, but a strategic business discipline that directly impacts timelines, investment decisions, and long-term product sustainability.
Our approach emphasizes:
- Structured regulatory assessment before execution
- Risk-based regulatory planning
- Alignment between regulatory strategy and technical execution
- Sustainable compliance throughout the product lifecycle
For this reason, we begin every engagement with a Regulatory Assessment Session, ensuring that regulatory execution is built on sound decisions rather than assumptions.
eCTD & Regulatory Execution Support
As part of our regulatory execution support, Bayt El Khebra El Dwaea provides advisory and implementation support for EXTEDO eCTD solutions in Egypt and the GCC, in collaboration with regional partners.
We approach eCTD not merely as a technical requirement, but as an integral component of regulatory execution strategy, ensuring:
- Structured and compliant submissions
- Effective lifecycle management
- Alignment with authority technical expectations
- Long-term regulatory sustainability
Training & Capacity Building
In addition to advisory services, we provide selective regulatory training and capacity-building programs designed to strengthen regulatory decision-making capabilities within pharmaceutical organizations.
Our training initiatives focus on:
- Regulatory strategy and thinking
- Market entry readiness
- Practical, decision-oriented regulatory expertise
These programs support organizations in building sustainable internal regulatory competence.
Our Commitment
At Bayt El Khebra El Dwaea, we are committed to:
- Regulatory integrity and accuracy
- Professional independence and objectivity
- Clear, transparent communication
- Practical, decision-oriented advisory
Our objective is to serve as a trusted regulatory reference for pharmaceutical companies operating in or entering the Egyptian and GCC markets.