In a field where precision, depth of knowledge, and credibility matter most, Sharlin Consulting stands out as a trusted partner for legal teams and regulatory professionals. Led by Joshua S. Sharlin, the firm brings a rare combination of scientific rigor and communication clarity to every engagement. With over 50 legal cases supported, including 22+ expert reports and more than 20 depositions, Sharlin Consulting has become a respected name for those seeking an FDA Regulatory Expert Witness or a seasoned FDA Compliance Consultant.
Expertise Built on Scientific Depth
Dr. Sharlin’s unique background spans multiple technical and regulatory disciplines. He is not only a seasoned FDA regulatory expert—he is also a biological scientist, statistician, software developer, data integrity specialist, and educator. This depth allows him to offer comprehensive support in cases involving FDA regulation of drugs, biologics, and medical devices.
Whether retained for expert testimony or consulting on compliance, Dr. Sharlin brings a factual, thoughtful, and analytical approach to every matter. His personal operating principle—“the truth makes the best story”—isn’t just a philosophy, it’s the backbone of his professional conduct and casework.
Reliable, Defensible Expert Testimony
As an expert witness, Dr. Sharlin has proven to be credible, clear, and thorough in both deposition and trial settings. He has never had an opinion excluded due to a Daubert challenge—a rare distinction that speaks volumes about the strength of his methodologies and documentation.
Legal teams rely on his ability to distill complex regulatory and scientific issues into clear, persuasive expert reports. His skills as a technical writer further reinforce the clarity and effectiveness of his contributions to legal strategy and courtroom presentation.
FDA Compliance Support That Holds Up Under Scrutiny
Beyond litigation support, Sharlin Consulting offers strategic guidance as an FDA Compliance Consultant. Companies developing or marketing pharmaceuticals, biologics, or medical devices can benefit from his insight into regulatory submissions, quality systems, and data integrity frameworks.
From the early stages of development to post-market compliance, Dr. Sharlin supports teams with practical, tailored advice based on real-world experience and technical acumen.
Why Legal Teams and Companies Choose Sharlin Consulting
- Over 50 cases of expert witness experience
- 22+ expert reports and 20+ depositions
- Proven credibility—no Daubert exclusions
- Multi-disciplinary background in science, software, and writing
- Clear communication and strong courtroom presence
To learn more about how Sharlin Consulting can support your regulatory or legal challenges, explore the full range of expert witness and FDA consulting services available.
