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
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.