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FDA Life News and Trends Impacting the FDA and Life Science Industry

Services

While life sciences businesses share many of the same concerns as companies in other industries, these issues must be addressed in the context of this highly regulated sector of the economy. Our multidisciplinary team of lawyers provides broad-spectrum, coordinated counsel on all major areas of law affecting clients’ operations and strategy. These core areas of service include labor and employment, intellectual property, state and local taxation, and international trade. Our experience in these and other areas of law enables us to provide prompt, effective counsel in the dynamic life sciences marketplace.

We work with clients on all aspects affecting their product lifecycle, including:

  • FDA submissions, inspections and responses to FDA Form 483s, warning letters and “Dear Manufacturer” letters
  • Marketing and promotion, including advertising, labeling and off-label use
  • Compliance analysis and counseling
  • Risk-management and litigation-avoidance strategies
  • Development, training and implementation of internal compliance programs
  • Regulatory analysis and counseling, with an emphasis on identifying possible FDA enforcement actions and developing strategies to limit potential investigations
  • Reviewing advertising and marketing initiatives for FDA and Federal Trade Commission (FTC) compliance
  • Negotiations with private equity investors, commercial banks and other financial institutions for capital sourcing
  • Product liability analysis and counseling
  • Corrective action plans, including negotiation of FDA Consent Decrees, responses to FDA compliance notifications and identification of key concerns that should be addressed to ensure ongoing compliance
  • Develop standard operating procedures (SOPs) to comply with FDA directives and current Good Manufacturing Practices (cGMP), quality system regulation (QSR) and inspections, as well as compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
  • Litigation, including defense of individuals and companies in FDA-related seizures, injunctions, grand jury investigations and criminal prosecutions, as well as in civil regulatory and enforcement matters at all levels of government
  • Recalls, product withdrawals and media relations
  • Due diligence for financial transactions with FDA-regulated companies