SHARLIN CONSULTING, LLC
Joshua Sharlin, Ph.D
Expert Witness, Pharmaceutical Regulation and Medical Devices
FDA Regulatory Consultant, Pharmaceutical
and Medical Device Expert Witness
Expert Witness (10 years)
Call: (410) 231-8900
25+ Years of Practice
Expert Witness
FDA Drug Warnings Medical Device Safety
Medical Device Safety/FDA
Consulting Services
Governance & Risk Management
Regulatory Relations
I am an FDA Regulatory Expert Witness and an FDA compliance consultant skilled in the regulations an submissions of drugs, biologics and medical devices. My experience includes 37 cases, 16 expert reports and 8 depositions. I have never been successful Daubert challenged.
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.
FOR MORE INFORMATION ABOUT SERVICES OFFERED, FEEL FREE TO CONTACT SHARLIN CONSULTING LLC BY EMAIL OR PHONE
MY SERVICES ARE
COMPREHENSIVE
Shalin Consulting LLC offers a number of services that cover a variety of areas revolving around FDA Regulations. Medical Device and Drug Death & Injury. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased testimony and identify both the strengths and weaknesses of a client’s case. As a former FDA Reviewer and +25 years of experience working in and with FDA-regulated companies you can be assured your case is in the best of hands.
MY EXPERIENCE IS COMPREHENSIVE
Shalin Consulting LLC offers a number of services that cover a variety of areas revolving around FDA Regulations. Medical Device and Drug Death & Injury. The majority of my work is in an expert witness role where I work closely with attorneys to provide unbiased testimony and identify both the strengths and weaknesses of a client’s case. As a former FDA Reviewer and +25 years of experience working in and with FDA-regulated companies you can be assured your case is in the best of hands.
FDA REGULATORY EXPERT WITNESS
Services Provided By Former FDA Reviewer & Current FDA Regulatory Expert Witness Dr. Joshua Sharlin (Ph.D).
FDA REGULATORY CONSULTANCY
DATA INTEGRITY SPECIALIST
TECHNICAL WRITER & EDUCATOR
Sharlin Consulting, LLC.
Joshua Sharlin, PH.D
jsharlin@pipeline.com
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