Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA Regulatory Consultant (25 Years)
Expert Witness (10 Years)

About Joshua Sharlin, PhD

  • Broad experience as an FDA regulatory expert witness, my cases include:
  • Death or injury caused by drugs, biologics or medical devices
  • Patents
  • Insurance claims
  • Wrongful termination
  • Trade secrets
  • Product labeling
  • Merger and acquisition
  • Stock manipulation
  • Comprehensive skills:
  • Biological scientist (Ph.D.), statistician
  • Software developer, data integrity specialist
  • Educator, FDA regulatory expert
  • Technical writer:
  • Expert reports, scientific publications
  • Audit reports from my FDA compliance inspections
  • FDA drug and medical device submissions
  • Data mining of FDA’s safety databases:
  • Extract adverse event information about drugs and medical devices
  • Create custom reports tailored to support a legal strategy
  • Produce information unavailable to users of FDA’s web site database interface
  • Teaching experience:
  • Over 50,000 people from more than a thousand FDA regulated companies have paid to hear my presentations
  • Skilled at clearly explaining complex information to a judge and jury
  • Hundreds of hours of experience speaking to groups