About Me

Dr. Joshua Sharlin

Sharlin Consulting, LLC.

FDA Related Skills, Experience & Qualifications

 

Former FDA reviewer  Expert at searching and understanding scientific  and medical publications
Ph.D.-level biological scientist  Identify and fix data integrity problems
Improve regulatory strategy  Audit and improve Trial Master Files
Audit companies, CROs, vendors and  clinical sites for FDA compliance Evaluate adverse event reporting compliance for  drugs and medical devices
Instructor on FDA topics  Perform software validation
Prepare clinical sites and companies  for an audit by FDA  Expert witness in lawsuits with an FDA regulatory  component
Answer written FDA questions  Speaker at meetings at FDA as a representative of  drug and medical device companies 
Write and improve clinical study  protocols and clinical study reports  Expert in analysis and interpretation of FDA safety  databases; MAUDE (medical devices), FAERS  (drugs)
Write drug and medical device  submissions  Conduct statistical analysis
Secret clearance (Dept of Defense)  Identify, prevent and solve compliance problems

Broad experience as an FDA regulatory expert witness, my cases include:

  • Death or injury caused by drugs, biologics or medical devices
  • Patent Infringement
  • Insurance Claims
  • Wrongful Termination
  • Trade Secrets
  • Product Labeling
  • Merger & Acquisition
  • Stock Fraud
  • Software Development

Technical Writer:

  • Expert reports, scientific publications
  • Audit reports from my FDA compliance inspections
  • FDA drug and medical device submissions

Comprehensive Skills:

  • Biological scientist (Ph.D.), statistician
  • Software developer, data integrity specialist
  • Educator, FDA regulatory expert
  • Public speaker

Data Mining of FDA’s Safety Databases:

  • Extract adverse event information about drugs and medical devices
  • Create custom reports
  • Produce information unavailable to users of FDA’s database dashboard

Teaching Experience:

  • Over 40,000 people from hundreds of 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

Sharlin Consulting, LLC.

Joshua Sharlin, PH.D

 

[email protected]

Cell: (410) 231-8900

Washington, D.C.

Get In Touch

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