Perham Gorji

• Conducted the investigation and review of a multinational pharmaceutical manufacturer’s pharmacovigilance systems related to adverse event reporting failures and advised the company on the implementation of proactive remediation measures and employment actions.
• Conducted a board-driven review of a multinational device manufacturer’s quality manufacturing systems to identify gaps in medical device reporting and connective and preventive action procedures following multiple FDA warning letters and a DOJ compliance agreement.
• Achieved victory for a large pharmaceutical company in a False Claims Act (FCA) qui tam case challenging the FDA approval of the company’s vaccine product.
• Represented a global pharmaceutical company in an off-label promotion and FCA investigation conducted by the DOJ. The matter was settled favorably for the client following a multiyear investigation.
• Conducted an investigation into a former employee’s whistleblower allegations into an alleged adverse event reporting violations during a clinical trial.
• Assisted a multinational device manufacturer with its FDA inspection response and FDA communication strategy.
• Assisted a food  retailer with its FDA inspection and 483 responses, with the FDA closing inspection without further regulatory action.
• Represented a multinational pharmaceutical manufacturer in a DOJ criminal investigation involving corporate officers alleged sourcing of counterfeit and/or mislabeled drug product for use in clinical trials.
• Provided clients with FDA and DOJ risk assessments in transactional due diligence matters.
• Guided a drug manufacturer’s response to a DOJ subpoena regarding its clinical trial practices and persuaded the DOJ to decline prosecution.
• Advised a client on its FDA consent decree exit strategy.

Perham Gorji advises health care, life sciences, and food & beverage companies on complex litigation, investigations, and regulatory enforcement matters, drawing on more than 20 years of federal service at the U.S. Food and Drug Administration (FDA) and the Department of Justice (DOJ). His background includes nearly a decade as deputy chief counsel for litigation at the FDA and more than a dozen years combined as a DOJ Consumer Protection Branch trial attorney and an assistant U.S. attorney.

With firsthand experience inside both the FDA and DOJ, Perham guides clients through enforcement actions, investigations, and litigation, helping them manage legal, regulatory, and reputational risk. He routinely advises companies responding to FDA warning letters, import alerts, and other regulatory actions, and counsels clients throughout the FDA inspection process, including product application, routine, for‑cause, and supervision inspections conducted pursuant to consent decrees or other government compliance agreements.

Perham’s practice covers the full range of FDA‑regulated medical products, spanning the complete  life cycle. He evaluates product offerings and manufacturing processes for compliance with applicable statutes and regulations and assists clients in developing and maintaining compliance programs and a culture of regulatory adherence.

Bar Admissions

• District of Columbia
• Delaware

Education

• Harvard University (J.D., 1998)
• Duke University (B.A., 1995)

Court Admissions

• U.S. District Court, District of Delaware