Shaking Hands

Specialized FDA knowledge on your side

We serve as an FDA litigation adviser, expert witness, or mediator for your firm.

Do you have a case that requires extensive knowledge of FDA or USDA legislation?

FDA litigation involves many complex regulatory questions. If you don’t have the expertise in-house, FDA Atty can provide highly specialized knowledge and guidance to your litigation team. 

For example, a product liability suit involving an injury from a medical device could raise questions regarding FDA approval, off-label use, and product classification. As an FDA expert, we can help your litigation team understand culpability and duty of care. 

We’re here to ensure your team has the knowledge they need to support your clients. 

FDA legislation

Litigation support in any FDA matter

With long-standing experience in FDA litigation and comprehensive understanding of FDA rules and regulations, we provide your firm with a competitive edge.

Litigation Adviser

As part of your litigation team, we help answer complex questions regarding regulations, compliance, culpability, and more. In order to build a winning strategy, we offer insight into how a product was approved or how the company complied with post-market responsibilities.

Expert Witness

We offer testimony for a wide range of topics including trademark, patent litigation, product liability, securities, and more. Details on compliance, misbranding, and other topics can prove key to winning a case. 

Mediation

Mediation is a tool used by courts and parties to avoid litigation. When a dispute involves FDA regulatory issues, a regulatory mediator like FDA Atty can help reach a resolution without you having to spend valuable time educating the mediator about FDA legislation.

Experience the FDA Atty Difference

Specialized assistance

We have 10+ years experience practicing FDA law, and lend our expertise to your litigation team for your case.

Cross-industry expertise

We are familiar with a range of highly regulated industries, including food, dietary supplement, beverage, cosmetic, medical device, and OTC drug.

Customized partnership

We can work directly with your clients or with your litigation team in any capacity. Our goal is to offer specialized knowledge in any case.

Comprehensive support

In addition to acting as a litigation adviser, expert witness, or mediator, we can also manage FDA document production and FOIA requests.

Here’s how to get started

  1. Book your free 20-minute consultation: We’ll get to know your business and share our knowledge of the related FDA legislation.
  2. Develop your regulatory strategy: We work together to create an action plan on how you can get your products approved by the FDA and noticed by your customers.
  3. Gain market share while ensuring compliance: We help you manage your risk by sharing how you can use language carefully on packaging and marketing.

Get clear direction on FDA legislation for your case