Dr. Sharlin's experience:
My key skill is identifying and developing facts supporting a legal strategy.

(1) Drug reviewer at FDA.

(2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8,
Testimony-1, Successful Daubert challenges-0.

(3) Professional experience: Regulatory consultant (25 years), expert witness (10 years).

(4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling.

(5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert.

(6) Talented technical writer, my writing experience includes:
 Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA.

(7) I write custom software for data mining of safety information from FDA's adverse event databases:
 I extract far more information from these databases than is possible using FDA's interface.

(8) My vast teaching experience allows me to present complex information in plain words to a judge and jury:
 Over 50,000 people from more than a thousand FDA regulated companies have paid to hear my presentations.

Specialties

• Pharmaceutical Regulation
• Medical Devices

Subpecialties

• FDA
• FDA expert FDA Compliance
• FDA Regulations
• FDA MAUDE
• FDA Drug Safety
• FDA Warnings
• FDA Drug Warnings FDA Medical Device expert
• FDA law
• FDA regulatory
• Drug Safety/FDA
• FDA Medical Devices
• Biologics Safety FDA
• Implant Safety/FDA
• Medical device product liability