Life Sciences


OUR Practice
Stradley Ronon’s life sciences practice group employs a comprehensive and collaborative interdisciplinary approach to tackle the wide-ranging business and legal needs of our life sciences clients. Our life sciences attorneys advise companies in Food and Drug Administration (FDA) regulation and compliance matters, corporate law, investment transactions, intellectual property law and specialized litigation matters. Our clients range from Fortune 500 public companies with multiple commercial brands to emerging companies developing nascent technologies. Our clients are active in the full spectrum of life sciences industries, including pharmaceutical, medical device, biotechnology and other FDA-regulated companies.

Life Sciences

OUR Experience
Our attorneys handle a broad array of life sciences matters in areas such as:

FDA Regulation & Compliance
We work with clients to resolve conventional and unique regulatory and compliance challenges of product development, approval and marketing. Our attorneys regularly advise pharmaceutical companies on commercialization strategies, achieving and maintaining compliance for marketed products, and advising on the regulatory aspects of products liability. We also have significant experience counseling cosmetic, food, beverage and dietary supplement product companies on their regulatory challenges. Our broad range of regulatory and compliance services includes:

  • representing clients in citizen petitions to the FDA
  • advising on legal standards and regulatory requirements for day-to-day core business operations during product development and commercialization 
  • providing legal regulatory support and risk management for Office of Prescription Drug Promotion (OPDP) labeling issues to meet promotional strategies and minimize product liability risk 
  • providing legal support for promotional review and medical/scientific review 
  • assisting clients in performing self-evaluative audits in cross-functional areas and designing corrective action plans 
  • extensive planning and implementation of Risk Evaluation and Mitigation Strategies (REMS) and legal support in preparation for FDA advisory committee meetings, with a focus on benefit risk, safety and risk management analysis, and counseling 
  • responding to government inquiries and document production 
  • assisting clients in developing cosmetic, food, beverage and dietary supplement product labeling and advertising practices in conformance with the law and FDA requirements

Risk Management & Litigation
Our seasoned trial team works closely with clients to identify and analyze risks associated with clinical trials, informed consent documents, labeling, advertising and post-marketing activities. We have significant experience in defending life sciences companies in commercial, intellectual property and products liability cases, as well as serving as national defense counsel in high-profile mass tort and products liability litigation throughout the United States.


Representative Matters

Stradley Ronon's recent successes for our life sciences clients include serving as counsel to: 

  • An international contract research organization (CRO) in its acquisition of a venture capital-backed CRO focused on later-stage clinical trials. 
  • A CRO in a private placement of $2 million in convertible preferred securities to angel investors. 
  • A venture capital fund in a Series A preferred stock investment in a drug discovery and development company focusing on small molecule therapeutics for central nervous system disorders. 
  • A pharmaceutical marketing services company in the development of a specialized services agreement that was accepted by various pharmaceutical companies in lieu of the typical master services agreement. 
  • A pharmaceutical services company in various rounds of institutional investment.
Back to top