Joshua Sharlin, Ph.D., founder of Sharlin Consulting, launches a dedicated webpage offering FDA regulatory consulting and expert witness services in pharmaceutical and medical device cases, covering death or injury, patent infringement, insurance claims, contracts, and criminal matters.
— Attorneys handling complex litigation involving FDA-regulated products can now access specialized regulatory expertise through the newly launched webpage of Joshua Sharlin, Ph.D., founder of Sharlin Consulting, LLC. The site highlights Dr. Sharlin’s availability as an FDA regulatory expert witness and consultant in legal matters involving pharmaceuticals, biologics, and medical devices.
Dr. Sharlin’s most differentiating skill and experience is his hands-on work on the entire lifecycle of FDA-regulated product development going far beyond just FDA regulatory expertise. This hands-on experience includes, developing regulatory strategy, writing study protocols, identifying and executing the most appropriate statistical analysis, writing code to perform data management and table generation, writing-up study results, auditing sites and vendors for compliance, presenting information to FDA and answering FDA ‘s questions, and his experience as an FDA reviewer, evaluating submissions for safety and efficacy.
What sets Dr. Sharlin apart as an expert witness is his direct, hands-on involvement in every phase of FDA-regulated product development—well beyond just regulatory knowledge. His experience spans designing regulatory strategies, authoring clinical protocols, selecting and implementing appropriate statistical methods, writing custom code for data management and table generation, and drafting clinical study reports. He has conducted compliance audits and solved compliance problems for study sites and vendors, presented complex data to FDA review teams, and directly responded to FDA inquiries. As a former FDA reviewer himself, he brings insider insight into how the agency evaluates safety, efficacy, and compliance in product submissions.
With more than 25 years of FDA compliance experience and a decade of expert witness engagements, Dr. Sharlin supports counsel in high-stakes cases involving:
Wrongful death or serious injury
Patent and trade secret litigation
Insurance disputes tied to FDA labeling or compliance
Contract and M&A disputes involving regulatory obligations
Stock fraud and SEC matters involving FDA-regulated disclosures
Off-label promotion, data integrity violations, and criminal charges
As a former FDA drug reviewer, Ph.D.-level biologist, and seasoned industry consultant, Dr. Sharlin delivers clear, courtroom-ready analyses of FDA submissions, compliance histories, labeling issues, clinical data, software integrity, and adverse event reporting (e.g., MAUDE, FAERS). He has served in more than 50 litigation matters, providing written reports, deposition testimony, and trial appearances.
Dr. Sharlin is also a recognized author and instructor, having developed and taught over 40 FDA compliance and regulatory strategy courses to professional audiences. His ability to translate complex technical and regulatory issues into clear, persuasive language has made him a valuable asset to legal teams across the country.
The new webpage provides:
A summary of expert services
Access to Dr. Sharlin’s CV
A sample case history list
Contact information for attorney inquiries
Attorneys seeking independent, scientifically grounded expert opinions on FDA regulatory issues are encouraged to visit the webpage to learn more about how Dr. Sharlin can support litigation strategy and strengthen regulatory arguments.
Contact Info:
Name: Joshua Sharlin, Ph.D.
Email: Send Email
Organization: Sharlin Consulting, LLC.
Phone: (410) 231-8900
Website: https://sharlinconsulting.com/
Release ID: 89166053
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