A new era for FDA GMP inspection preparation and regulatory intelligence has arrived.
FDAzilla services have been utilized by hundreds of clients, ranging from small pharmaceutical firms to investment banks to Fortune 500 companies in every FDA-regulated industry. Cited by major media outlets such as MSNBC, WSJ, and the Boston Globe, FDAzilla.com has been viewed more than 1 million times per year.
In 2010, the FDAzilla team spotted the growing need for trustworthy and timely FDA intelligence. By simplifying the complicated world of FDA documents and databases, FDAzilla provides data analytics, intelligence services, and inspection documents to FDA-regulated companies seeking an advantage. Equipped with this unrivaled information, FDAzilla customers can effectively:
- Prepare for FDA inspections
- Perform due diligence on partners and competitors
- Save time and money
- Minimize the risk of an FDA GMP enforcement action
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Tony Chen is CEO and Co-Founder of FDAzilla. Tony began his career as an Analyst at Merck, where he was one of the first emerging leaders to be chosen as part of the Manufacturing Management Development Program. Among other accomplishments, Tony successfully led several multi-national project teams to streamline critical manufacturing processes. Tony has also worked as Director of New Product Development at a teaching hospital affiliate of the University of Chicago Pritzker School of Medicine. Here, he led efforts to market and license a patent portfolio that included several novel compounds, molecular targets, and medical device innovations.
Tony has a passion for synthesizing business intelligence, as evidenced by his founding of a healthcare digital company in which he recruited 3 healthcare CEOs to collectively produce 800+ articles. This business was acquired in 2008 by FierceMarkets, a prominent digital publishing company. Tony has also covered the pharmaceutical/life sciences sector as an equity research analyst for Zacks Investment Research and worked for a healthcare management association focused on data analytics as Director of Product Innovation.
Tony earned his BS in Chemical Engineering from Cornell University and earned his MBA from The Kellogg School of Northwestern University.
Oliver Yu is CTO and Co-Founder of FDAzilla. He comes with 18+ years of pharma/biotech manufacturing experience at Genentech, Zymergi, and Cygnus, where he focused on large-scale data analysis, process automation, cell culture, sterility, and yield optimization.
Oliver earned a Master of Engineering in Chemical Engineering and a B.S. in Agricultural and Biological Engineering from Cornell University.
Barbara serves as FDAzilla’s in-house GMP Quality Expert and is Editor-in-Chief of FDAzilla's GMP Regulatory Intelligence. Most recently she was the Director of External Quality for Amgen. There she designed, developed, implemented, and managed a sophisticated and comprehensive GMP Regulatory Intelligence program for 8 years. A key part of that program was surveillance of the environment on a daily basis and communication of time-sensitive and business-critical information to relevant management and staff in real time. Her newsletter inside Amgen was distributed broadly across the company - from VPs to front-line quality, operations, development, and regulatory personnel.
Barbara has also been an industry leader in the area of GMP Regulatory Intelligence. Barbara was a leader in Rx-360, the pharmaceutical and device global supply chain consortium founded in 2009. She was the founding chairperson for the Monitoring and Reporting team that identified and published summaries of new and revised GMP and GDP laws, regulations, and guidance that impacted the pharmaceutical and device industries. She led the group from its inception in 2009 through 2014. She was chairperson of the GMP Intelligence Midwest Discussion Group from 2010-2014.
Email Barb at GMPnewsletter@FDAzilla.com.