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Wynngate Corporation offers quality solutions by bringing FDA and industry expertise to worldwide clients.
Wynngate Corporation (aka Wynngate Consulting) was founded by Binh Nguyen, Pharm.D., M.S., BCSCP, FHPE in 2024 after 20+ years of working for the USFDA and UCI Health Hospital as a pharmacist and 1 year with Lachman Consultants. His vision is to provide quality solutions to the bio/pharmaceutical industries including combination products to ensure high quality products continue to be available to patients whether it is in the United States or anywhere in the world. Wynngate Consulting is dedicated to helping bio/pharmaceutical companies overcome their most complex challenges including CGMPs compliance, FDA-483/Untitled Letter/Warning Letter responses, remediation, CGMP training, remediation, corrective actions, FDA mock audits, and internal audits.
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About Company
Dr. Binh Nguyen retired from FDA in March 2023 after 20 years specializing in pharmaceutical training, compliance, management, and inspectional audits for CDER (Center for Drugs Evaluation and Research) and ORA (Office of Regulatory Affairs). He was a Level III Certified Pharmaceutical Inspectorate, a Level II Drug Auditor, drug branch chief, and director regulatory review officer for biotech, sterile injectable, sterile compounding, positron emission tomography, combination products, and other dosage forms. He also worked as a clinical and compounding pharmacist at a UCI Hospital, a 400-bed acute care hospital for 21 years. He served as a counsel member in sterile compounding pharmacy for the Board of Pharmacy Specialties for 3 years. He completed his doctorate in pharmacy and master in regulatory science at the University of Southern California. He is the founder and developer for the global inspection software with AI called ieQip (intelligent electronic Quality inspection platform) which can be used as independent third party or internal audit. He consulted for Lachman Consultants prior to launching Wynngate Corporation in March 2024.
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About Leadership
At Wynngate Consulting, we are dedicated to helping organizations overcome their most complex challenges. With our comprehensive capabilities and deep bio/pharmaceutical industry knowledge, we provide tailored solutions that drive growth and success. We have ex-FDA and industry experts to deliver mock FDA audits and internal training to prep your companies to be inspection ready.
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About Our Team
OUR TEAM
Our team doesn't just stop at providing a one-time service but continues to support clients throughout their products' journey, helping them adapt to changing circumstances and market demands.
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