With over 20 years of experience in the life science industry, I am the Owner of Premier FDA Solutions, LLC, a company that provides quality system remediation planning and execution, staff augmentation, GxP auditing, and FDA expert witness support for pharmaceutical, medical device, biotech, and diagnostics companies and the companies that support them. My passion is to help my clients achieve and maintain compliance with the FDA and other regulatory agencies, and to enable them to deliver safe and effective products to the market.As a former Vice President of Business Development at The FDA Group, LLC, and a Senior Director of Business Development at Clinipace Worldwide, I have a proven track record of successfully selling and managing large, complex projects to life science executives and professionals nationwide. I have built strong relationships with key decision makers and have leveraged my extensive network of FDA, quality, and regulatory experts to provide the right compliance expertise at the right time. I have also contributed to the growth and recognition of both companies, leading them to be among the Inc. 500/5000 Fastest-growing private companies for several consecutive years. My specialties include creating and negotiating proposals, business plans, contracts, and agreements, as well as developing and executing strategic and tactical sales plans. I have a strong understanding of the full drug/device life cycle, from the clinical and pre-clinical research development process, to the quality and regulatory compliance process, to the commercial selling/marketing.