About Us
xFDA is a leading consulting firm specializing in FDA regulatory affairs, compliance, and quality systems. Our team of over 150 former FDA experts brings decades of experience in the approval and clearance processes for drugs, biologics, and medical devices. We partner with companies of all sizes to navigate the complexities of FDA regulations efficiently and effectively.
Meet the Team
Our team of over 150 former FDA experts brings decades of experience in regulatory affairs and compliance. We work collaboratively to provide tailored solutions that help our clients navigate FDA regulations efficiently and effectively.
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Mr. Walls is COB of xFDA, INC. His business career and government employment span over 40 years. His experience with the US Government in high level positions of increasing responsibility include: Senior Consultant in the Office of Economic Opportunity - Office of President, Deputy Regional Director - Office of Minority Business Enterprise, OMBE, US Department of Commerce, DOC, Director - Office of Business Relations - Agency for International Development (AID) Director Office of International Business Development - US Department of Agriculture, USDA, Executive Director, Presidential Council for Vocational Education, PCV
He has over 25 years of successful business experience. President of Inner Search Foundation, Inc. and owner of a franchise of twelve restaurants. Mr. Walls is highly skilled in determining management directions involving short and long term planning. Some of his greatest strengths are with interpersonal relations. He is an author of two books and has a continuing involvement as a professional healer and teacher.
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Primary job responsibilities are to ensure that all lines of business within the organization are running efficiently and within the budget set forth by the officers of the company and finance officer. She works with other company officers to devise a strategic plan that will generate revenues, create new opportunities for business and help the company to remain competitive in the marketplace. Her strong emphasis on cost management is a critical component to the company's success. Other responsibilities include, overseeing the company's financial information, she creates company and performance objectives and has a strong managerial presence.
Her experience also includes President of Advertising and Marketing Strategies, Inc. For over 20 years she was involved in the planning, development and marketing of individual projects for clients. Background has been in advertising and business leadership positions. This has provided a depth of understanding about a wide range of activities in managing a variety of companies. These extensive business activities have expanded Ms. Wall's abilities to know each level of business operations. She was responsible for overseeing the different functions that serve clients, by creating, developing and implementing sales promotion. This included copywriting, media selection and production, account services and finance. She communicates the clients' needs and overall vision. She manages marketing and sales by using demographic research to determine the best advertising strategy for clients. Other duties include supervising organizational management and financial issues, such as billing, accounts payable, human resources and staffing.
Ms. Walls is skilled at operations, marketing, strategy, financing, planning and meeting deadlines and overseeing projects. She is thoroughly familiar with standard business practices. Works well with people. Committed to excellence and achieving success at all levels. Ms. Walls is an excellent communicator and listens well to others. BA - Business Administration - Brooklyn College, Brooklyn, NY
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Dr. Apfel is a former FDA CMC expert and is an expert in FDA regulatory submissions. Dr. Apfel brings chemistry, manufacturing, and controls (CMC) guidance to the pharmaceutical industry, interprets regulations, and prepares or advises on the preparation of the CMC portion of applications for FDA submission. She advises on analytical issues, impurities, clinical supplies and packaging issues, drug substance and drug product stability issues, and all facets of the planning of the CMC portion of a project from the early stages through post approval. She has over twenty five years of accomplishments in regulatory science: research and pre-formulation in industry (Parke-Davis/Warner-Lambert) and academia (University of Kansas), reviewing new drug and generic drug applications at the FDA, and advising pharmaceutical firms on applications as a consultant since 1997. She began her eight years at the FDA as a review chemist and later served as the liaison to the pharmaceutical industry for SUPAC post-approval changes. Dr. Apfel has lectured and has authored patent and scientific publications. Dr. Apfel earned a Ph.D. in Medical Biochemistry from the University of Minnesota (Minneapolis).
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Dr. Sherry serves as the Executive Vice-President of Business Development and Clinical Affairs. He is a board certified in Neurology with over 20 years of clinical, research, and regulatory experience. Prior to joining xFDA, Dr. Sherry was the Medical Director at Mylan Laboratories and Vice-President, Clinical Research at Mylan-Bertek Pharmaceuticals
His duties as Medical Director included managing the pharmacovigilance program for over 100 drug products, assisting with business development, and working with the Marketing departments. During his time at Mylan-Bertek Pharmaceuticals, he was responsible for the development of branded products. He successfully led the development of three compounds through NDA submission. One of which received a priority review and rolling submission. Prior to joining Mylan, Dr. Sherry served as a Medical Reviewer in the Division of Neuropharmacologic Drug Products at the Food and Drug Administration (FDA).
Dr. Sherry received his Ph.D. degree in Physiology, with an emphasis on drug metabolism, from West Virginia University. He subsequently received his M.D. from West Virginia University. He completed his residency in Neurology at Bethesda Naval Hospital / National Naval Medical Center. After serving two years as a general Neurologist, he completed a clinical Neurophysiology Fellowship at Walter Reed Medical Center. Dr. Sherry served for a combined 16 years in the United States Navy and the United States Public Health Service, Commissioned Corps.
Our Values
At xFDA, our values guide our approach to helping clients navigate the complexities of FDA regulations
Expertise
With over 150 former FDA experts, we offer in-depth knowledge and experience in regulatory affairs and compliance to ensure success in the approval process.
Integrity
We prioritize transparency and ethical conduct, providing our clients with honest, reliable advice at every step of their journey.
Collaboration
We work closely with our clients to understand their unique needs and deliver tailored solutions that streamline the regulatory process.
Quality
We are committed to excellence, ensuring that every service we provide meets the highest standards of regulatory compliance and efficiency.
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Partner with xFDA
With over 150 former FDA experts and decades of experience, xFDA is dedicated to guiding you through the complexities of FDA approval and compliance. Contact us today to learn how our tailored solutions can help streamline your regulatory process and ensure your product’s success.