FDA Regulatory Consultant
Pharmaceutical
& Medical Device Expert Witness
FDA Regulatory Consultant (25+ Years)
Expert Witness (10 years)
CONTACT SHARLIN CONSULTING LLC
Expert Witness Experience
– Death or Injury
– Patent Infringement
– Insurance Claims
– Contracts
– Criminal Charges
– Failure to Warn
– Trade Secrets
– Merger & Acquisitions
– Wrongful Termination
– Non-compete ClausesÂ
– Stock Fraud
– Software Development
– Data Integrity
– Arbitration
– Off-label Use
I am an FDA regulatory expert witness and an FDA compliance consultant skilled in the regulations and submissions of drugs, biologics and medical devices. My expert witness experience includes 50+ cases, 22+ expert reports and 20+ depositions, testified 5 times. I have never had an opinion excluded because of a Daubert challenge.
I have broad and deep knowledge and experience as a biological scientist, statistician, software developer, data integrity specialist, technical writer, educator and FDA regulatory expert.
I have significant experience rescuing clinical trials and FDA submissions at risk of failure due to compliance and content problems.
FOR MORE INFORMATION ABOUT SERVICES OFFERED
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.
Shalin Consulting LLC offers a variety of services related to FDA product submissions including techinal writing, solving compliance problems and auditing sponsors, vendors, CROs, clinical sites and software providors. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased opinions and identify both the strengths and weaknesses of a client’s case.
Sharlin Consulting LLC offers a variety of services related to FDA product submissions including techinal writing, solving compliance problems and auditing sponsors, vendors, CROs, clinical sites and software providors. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased opinions and identify both the strengths and weaknesses of a client’s case.
FDA Regulatory Expert Witness
Services provided by former FDA reviewer & current FDA regulatory expert witness, Joshua Sharlin Ph.D.
In Depth Experience with Failure to Warn
Expert in Software Development
Technical Writer & Educator
Sharlin Consulting, LLC.
Joshua Sharlin, PH.D
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.