HICKORY HILLS, IL, September 14, 2026 /24-7PressRelease/ -- Deyaa Shaheen has been selected for inclusion in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.
Mr. Shaheen currently serves as founder of XFDA Pharma Advisors Consulting Services, a firm he established in 2025 in Chicago, Illinois. Under his leadership, the company has become a trusted partner for organizations worldwide seeking to achieve successful U.S. Food and Drug Administration inspections and bring their products to the United States market. XFDA Pharma Advisors Consulting Services specializes in developing remediation plans, ensuring compliance with FDA regulations and responding to warning letters and Form 483 observations. The firm provides independent third-party assessments, oversight, inspection readiness activities and expert coaching during inspections. Mr. Shaheen personally advises on all projects and leads select engagements, drawing on his extensive regulatory experience.
The company's services include assessing quality systems and manufacturing capabilities of laboratories, conducting due diligence audits during acquisitions and performing data integrity assessments and remediation. XFDA Pharma Advisors Consulting Services also assists with root cause analysis, critical thinking, oversight of contract manufacturing organizations and guidance through successful inspections. The firm manages pre-approval inspections, conducts baseline assessments of surveillance inspection systems, and provides comprehensive training programs. Additionally, it develops detailed remediation plans and reviews new product applications submitted to the FDA, with a particular focus on the Chemistry, Manufacturing, and Controls section. The company's reach extends across the United States, India, the Asia-Pacific region, Europe, Canada and South America.
Before founding XFDA Pharma Advisors Consulting Services, Mr. Shaheen was a senior director at Lachman Consultant Services Inc. from 2024 to 2025. In this capacity, he provided strategic guidance on global quality and compliance matters for clients navigating complex regulatory environments.
From 2023 to 2024, Mr. Shaheen held the position of senior director of global quality and compliance for global corporate audit and inspection readiness at Baxter in Deerfield, Illinois. He was responsible for overseeing global audit programs and ensuring organizational preparedness for regulatory inspections.
Between 2021 and 2023, Mr. Shaheen served as director of global compliance at KBI Biopharma. His role involved managing compliance initiatives across multiple sites and supporting the company's efforts to maintain high standards in quality assurance.
Mr. Shaheen was associate director of global auditing at Merck & Co., Inc. from 2020 to 2021. He led international audit teams in evaluating manufacturing operations for adherence to regulatory requirements.
From 2014 to 2020, Mr. Shaheen worked as a drug investigator in the Office of Regulatory Affairs and as a compliance officer in the Center for Drug Evaluation and Research/Office of Compliance/Office of Manufacturing Quality at the U.S. Food and Drug Administration in White Oak, Maryland. During his tenure with the FDA, he conducted approximately 50 international inspections—three of which resulted in warning letters, including one with national impact—and worked at over 150 facilities worldwide, completing more than 325 inspections or audits throughout his career. He is recognized for his commitment to safeguarding public health by ensuring that products reaching consumers are safe and effective.
Earlier in his career, Mr. Shaheen was a quality assurance specialist III at MedImmune (now AstraZeneca) in Frederick, Maryland, in 2014, where he contributed to the organization's quality assurance operations.
From 2011 to 2014, he served as internal auditor and lead technical data reviewer at Hospira, where he played a key role in internal auditing processes and technical data review.
In addition to his professional roles within the pharmaceutical industry, Mr. Shaheen is also a former professional volleyball player—a testament to his discipline and dedication both inside and outside his primary field.
Mr. Shaheen earned a bachelor's degree in chemistry from Alexandria University in Alexandria in 1993. His academic background provided a strong foundation for his subsequent achievements in pharmaceutical quality assurance and regulatory compliance.
He has further distinguished himself through several professional certifications: certified manager of quality/organizational excellence from the American Society for Quality, awarded in 2022; service-focused leadership certification from InResources Inc., received in 2021; lean six sigma green belt from The Quality Group GmbH, obtained in 2014; and certified quality auditor from the American Society for Quality, also achieved in 2014.
Mr. Shaheen attributes his success to the unwavering support of his wife and daughter, who have encouraged him throughout his journey, as well as to the inspiration of his parents, who instilled in him the values of integrity, service, honesty and dedication during his upbringing.
Born in Alexandria, Mr. Shaheen is fluent in English, French and Arabic. This skill set has enabled him to work effectively across diverse regions, including Egypt, Canada and the United States.
Outside of his professional commitments, he enjoys playing volleyball and soccer, swimming, hiking, working out at the gym, and spending time with his daughter.
Looking ahead, Mr. Shaheen aims to expand his team by bringing on additional professionals to engage in more projects globally, assist companies in developing successful profiles with the U.S. Food and Drug Administration while prioritizing product safety and efficacy for clients, and broaden his portfolio within the pharmaceutical and biopharmaceutical industries.
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