FDA Regulatory Consultant
Pharmaceutical
& Medical Device Expert Witness
FDA Regulatory Consultant (25+ Years)
Expert Witness (10 years)
CONTACT SHARLIN CONSULTING LLC
Expert Witness Experience
– Death or Injury
– Patent Infringement
– Insurance Claims
– Contracts
– Criminal Charges
– Failure to Warn
– Trade Secrets
– Merger & Acquisitions
– Wrongful Termination
– Non-compete Clauses
– Stock Fraud
– Software Development
– Data Integrity
– Arbitration
– Off-label Use
I am an FDA regulatory expert witness and an FDA compliance consultant skilled in the regulations and submissions of drugs, biologics and medical devices. My expert witnes experience includes 50+ cases, 22+ expert reports and 20+ depositions, testified 5 times. I have never had an opinion excluded because of a Daubert challenge.
I have broad and deep knowledge and experience as a biological scientist, statistician, software developer, data integrity specialist, technical writer, educator and FDA regulatory expert.
I have significant experience rescuing clinical trials and FDA submissions at risk of failure due to compliance and content problems.
FOR MORE INFORMATION ABOUT SERVICES OFFERED
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.
Shalin Consulting LLC offers a variety of services related to FDA product submissions including techinal writing, solving compliance problems and auditing sponsors, vendors, CROs, clinical sites and software providors. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased opinions and identify both the strengths and weaknesses of a client’s case.
Sharlin Consulting LLC offers a variety of services related to FDA product submissions including techinal writing, solving compliance problems and auditing sponsors, vendors, CROs, clinical sites and software providors. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased opinions and identify both the strengths and weaknesses of a client’s case.
FDA Regulatory Expert Witness
Services provided by former FDA reviewer & current FDA regulatory expert witness, Joshua Sharlin Ph.D.
In Depth Experience with Failure to Warn
Expert in Software Development
Technical Writer & Educator
Sharlin Consulting, LLC.
Joshua Sharlin, PH.D
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.
Get In Touch
About Joshua Sharlin, PhD
Joshua Sharlin applies his insight about FDA compliance and regulatory affairs (former FDA reviewer), and knowledge about science (PhD in physiology) to analyze and explain regulatory and compliance-related issues involving FDA-regulated companies.
His skills include data integrity and software development which were perfected while working as Director of Hotel Customer Information Systems for Marriott.
Dr. Sharlin is a specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?
He began supporting attorneys as an FDA regulatory expert in 2002. His experience includes testifying and being deposed. He currently splits his time as a regulatory affairs consultant (75%) and as an expert witness (25%).
Dr. Sharlin is a strong public speaker and skilled teacher. Over 50,000 people have learned from hundreds of his presentations on over 40 FDA-related technical and regulatory topics. Finally, he consistently writes opinions that strongly support an attorney’s case.
Expert Witness Cases
- Hip implants
- Device implants
- Warning on drug label
- Critique report written by another expert
- Fentanyl, Actos, breast cancer drug, ADHD drug
- Evaluation of adverse event reporting
- Wrongful firing
- Drug approval process
- Trade secrets
- Clinical trial design
KEY SKILLS, EXPERIENCE & QUALIFICATIONS
- Former FDA reviewer
- Write expert reports on safety and FDA compliance of hip implants
- Skilled in depositions and testimony
- Vast experience as an auditor of FDA compliance
- Expert in software development
- Confirm data integrity
- Speaker at FDA meetings with drug and medical device companies
- Critique adverse event reporting
- Support attorneys in cases involving sulindac, fentanyl, Actos, breast cancer drugs and ADHD drugs
- Perform statistical analysis
- Identify, prevent and solve FDA compliance problems for drug and device companies of all sizes
- Trained over 50,000 people on more than 40 FDA-related technical and compliance topics
- Write submissions, SOPs, study reports
- Testify as an FDA expert witness in drug, biologic, and medical device cases