FDA Regulations Expert Witnesses in Indiana

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FDA regulations expert witnesses practice in a variety of fields, including pharmaceuticals, food safety, medical devices, biotechnology, and cosmetics. Some of the most common FDA regulations expert witness specialties also include drug safety, labeling compliance, dietary supplements regulation, clinical trials oversight, and quality control. They can opine on the effects of regulatory compliance, product recalls, adverse event reporting, Good Manufacturing Practices (GMP), and new drug approval processes.

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George CalafactorView profile

ID: 12766

Mr. George Calafactor

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Indiana

This highly-qualified expert has decades of experience working in medical device regulation and compliance. He earned a BS in chemistry as well as metallurgical engineering from the University of Notre Dame, an MS in regulatory affairs at Northeastern University, and an MBA in international business at Indiana University. He is a certified quality biomedical auditor and a certified medical device...

Specialties:

The Average FDA Regulations Expert Witness
Charges $509 / Hour

Based on hourly rates. Compare expert witness rates across thousands of specialties in all 50 states.

  • Review Fee

    $450

    Fee info

    This represents an expert’s hourly rate for participating in depositions. Experts may charge more for depositions that require them to travel, and some experts choose to bill a flat, daily or half-daily rate for deposition appearances.

  • Deposition Fee

    $550

    Fee info

    This represents an expert’s hourly rate for participating in depositions. Experts may charge more for depositions that require them to travel, and some experts choose to bill a flat, daily or half-daily rate for deposition appearances.

  • Court Fee

    $525

    Fee info

    This represents an expert’s hourly rate for participating in depositions. Experts may charge more for depositions that require them to travel, and some experts choose to bill a flat, daily or half-daily rate for deposition appearances.

FDA Regulations Expert Witness FAQs

An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.

Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.

Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.

Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.

They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.

Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.

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