Joshua Sharlin Ph.D., Sharlin Consulting
129 Tanners Point Drive Stevensville, MD 21666
Skilled at writing expert reports that describe (or explain) safety and compliance-related errors committed by FDA-regulated companies and their outsourcing partners. Expert in FDA regulatory requirements for software development and data integrity.
Specialist in analyzing drug/device safety-related data and FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?
Skilled in writing 510(k), IDE, PMA, IND, NDA, SOP