Jessica Ringel

• Assisted medical device, pharmaceutical, and cosmetics companies with strategy for and responses to 100+ FDA 483s, Warning Letters, Untitled Letters, and It Has Come to Our Attention Letters.
• Advised medical device, pharmaceutical, and compounding firms in negotiation of, defense against, operations under, and exits from FDA Consent Decrees of Permanent Injunction.
• Completed successful appeals for adverse FDA marketing application decisions for a neurological device manufacturer and a dermatology device manufacturer.
• Conducted FDA regulatory due diligence for numerous mergers, acquisitions, and investments in device, pharmaceutical, cosmetics, and personal care targets on behalf of life sciences manufacturers, private equity firms, SPACs, and investment firms.
• Conducted and supported internal investigations of employee compliance complaints for medical device and other life sciences companies.
• Completed secondments and provided in-house legal support for advertising and promotion compliance for a large pharmaceutical company and an interventional device firm.

Jessica Ringel helps life sciences companies navigate FDA regulatory compliance, manage enforcement risk, and keep products on the market. She advises on FDA regulatory strategy and submissions, inspections, warning letters, recalls, marketing, and import detentions, helping clients resolve complex regulatory challenges, maintain business continuity, and avoid costly disruptions. She also supports transactions with FDA-focused due diligence and risk assessment.

Jessica works with medical device, pharmaceutical, and cosmetics companies to address FDA regulatory challenges that affect product development, market access, and ongoing operations. Jessica helps clients develop and execute regulatory strategies, including selecting pathways to market, preparing FDA submissions, and obtaining agency feedback needed to advance commercialization.

Jessica advises on high-stakes post-market issues, including FDA inspections, FDA 483 observations, Warning Letters, and consent decrees. She provides practical guidance on corrective actions and remediation plans designed to resolve issues efficiently while minimizing disruption. She also counsels clients on product recalls, adverse event reporting, and advertising and promotion, helping them manage safety concerns and regulatory risk in real time.

Jessica regularly assists companies facing FDA import detentions, working to secure product release and limit supply chain disruption. She also advises on specialized regulatory frameworks, including those applicable to HCT/Ps and electronic products subject to FDA radiation control requirements.

In addition, Jessica supports life sciences transactions with FDA-focused due diligence. She evaluates compliance history, identifies regulatory risk, and advises on deal terms and risk allocation so clients can move forward with greater certainty.