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
