With an illustrious career spanning 25 years as an FDA Regulatory Consultant and a decade as a prominent expert witness, Joshua Sharlin, the founder of Sharlin Consulting, stands as a seasoned authority in the intricate realm of pharmaceutical and medical device regulations.
Sharlin’s journey as an FDA Regulatory Consultant has been marked by a continuous commitment to excellence. Over the past 25 years, he has honed his skills and deepened his knowledge, becoming a trusted advisor to companies navigating the complex landscape of FDA regulations. His consultancy services extend far beyond mere compliance, encompassing a comprehensive understanding of the evolving industry standards and best practices.
In the last 10 years, Sharlin has made a significant impact as an expert witness, participating in 50 cases, preparing 22 expert reports, engaging in 15 depositions, and testifying three times. Notably, he has never been successfully Daubert challenged, underscoring the reliability and credibility of his testimony in legal proceedings related to FDA regulations.
What sets Sharlin apart is not only his extensive experience but also the diverse skill set he brings to the table. As a biological scientist, statistician, software developer, data integrity specialist, technical writer, and educator, he approaches regulatory challenges with a multifaceted perspective. This comprehensive expertise allows him to address not only the immediate compliance needs of his clients but also to optimize processes and foster a culture of regulatory excellence.
In addition to his role as a consultant and expert witness, Sharlin has dedicated himself to sharing knowledge with industry professionals, contributing to the continuous growth of regulatory expertise within the pharmaceutical and medical device sectors. His enduring commitment to staying ahead of industry trends ensures that his clients benefit from the latest insights and advancements in FDA regulations.
Joshua Sharlin‘s 25-year tenure as an FDA Regulatory Consultant, coupled with a decade as an expert witness, showcases a career marked by unwavering dedication, versatility, and a profound impact on the regulatory landscape of the pharmaceutical and medical device industries.
