Greenleaf is expanding the firm’s litigation support services to include a network of experienced and knowledgeable FDA experts adept at advising litigators representing FDA-regulated clients. Greenleaf’s litigation support services utilize the firm’s deep bench and network of experienced and knowledgeable FDA experts to advise litigators grappling with FDA regulatory issues and provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.

Comprehensive Services
Greenleaf professionals and the firm’s network of experts work closely with litigators representing FDA-regulated clients in a wide array of disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance. The firm offers litigators access to advisors with the knowledge, qualifications, and experience required to explain and clarify complex FDA regulatory issues to clients, the courts, or juries and serve as credible, persuasive expert witnesses.

Services provided by the Litigation Support Services Network include: advising litigators on the nuances of FDA regulation; preparing expert declarations or reports; and testifying during depositions and at trial. Greenleaf’s team has worked with litigators engaged in a variety of disputes, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions.

Areas of Expertise
Greenleaf professionals and the firm’s network of experts have extensive, in-depth experience regarding medical device product development, drug and biological product development, the premarket review process, as well as manufacturing, product quality and safety, compliance, and enforcement of all FDA-regulated products.

The Greenleaf Litigation Support Services Network can offer litigators a high-level institutional knowledge of the FDA as well as more granular expertise regarding FDA regulation of a variety of product types across the product lifecycle. Greenleaf’s well-regarded professionals have spent decades working at the FDA in senior positions, allowing them to render thoughtful advice and authoritative opinions.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.