Sharlin Consulting provides expert witness services for complex legal cases requiring deep expertise in FDA regulations. Led by Joshua Sharlin, PhD, a seasoned FDA regulatory expert, the firm specializes in cases involving drugs, biologics, medical devices, patents, insurance claims, wrongful termination, and more. With over 50 cases, 20+ depositions, and a reputation for providing solid, reliable testimony, Sharlin Consulting offers a unique combination of scientific rigor and legal acumen.
Extensive Expertise in FDA Regulatory Matters
Joshua Sharlin’s experience spans a broad range of industries and regulatory issues. As an FDA regulatory expert witness, he has helped clients navigate cases related to drug and medical device safety, product labeling, mergers and acquisitions, stock manipulation, and trade secrets. His expertise is supported by a PhD in biological science, statistical analysis skills, and a deep understanding of software development and data integrity.
Sharlin Consulting’s specialized knowledge is particularly valuable in FDA compliance, including complex submissions for drugs, biologics, and medical devices. Dr. Sharlin’s insight into these areas has proven invaluable in legal proceedings involving safety issues, patent disputes, and regulatory concerns.
Comprehensive Services for Legal Professionals
Sharlin Consulting’s role as an expert witness includes:
- Expert Reports – Comprehensive, scientifically backed reports that support litigation strategies.
- FDA Drug and Medical Device Submissions – Detailed submissions for regulatory approval and compliance.
- Adverse Event Data Mining – Extracting and analyzing safety data from the FDA’s extensive databases to support legal cases.
- Technical Writing – Reports, publications, and audit reports based on FDA inspections.
- Clear Testimony – The ability to clearly present complex scientific data to judges and juries.
Dr. Sharlin’s experience also extends to educating over 50,000 people from more than 1,000 FDA-regulated companies. His ability to translate complex scientific information into digestible, understandable terms for legal professionals is a core strength. This makes him a highly sought-after expert in cases that require an understanding of both the science and the legal ramifications of FDA regulations.
Reliable, Unbiased Testimony
When it comes to providing testimony in legal cases, Joshua Sharlin, PhD is known for his integrity and consistency. With over 20 expert reports and 5 depositions, he has built a solid reputation for delivering unbiased testimony. His operating principle is that the truth makes the best story, and his approach is rooted in a commitment to accuracy and transparency. Notably, Dr. Sharlin has never had his opinion excluded due to a Daubert challenge, solidifying his credibility as an expert witness in FDA regulatory matters.
For legal teams in need of a trusted FDA regulatory expert witness, Sharlin Consulting offers unparalleled expertise and experience. Dr. Sharlin’s approach combines scientific analysis, regulatory knowledge, and legal insight to provide effective, compelling support for any case.
