Joshua Sharlin, PhD
Medical Devices Expert Witness, Pharmaceutical Regulation Expert Witness
FDA Drug Safety,
FDA Drug Warnings
FDA Medical Device Safety,
Hip Implant Safety/FDA,
Medical Device Safety/FDA,
Biologics Safety FDA,
Have provided Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics or medical devices, (ii) patents, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions. Expert in data integrity and software development. Talented in testimony and depositions.
Hands-on experience in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA.
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Specialist in analyzing 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? (Se...
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