Regulatory & Compliance

Government regulation has grown in size and complexity. Regulatory compliance is critical to day-to-day business decisions, future company planning and overall risk management.

Regulatory requirements are ever changing, and compliance missteps can result in government investigations and enforcement actions, drain company resources, limit opportunities and impact a company’s reputation. In worst case scenarios, non-compliance can result in significant monetary penalties and even prison time.

Our clients often face regulatory and compliance issues in the “grey zone” where laws and regulations are not clear, when they are not clearly applicable to the situation at hand, or sometimes when there are no laws or regulations to apply. While it’s not always easy to mesh “real life” situations with regulatory requirements, our lawyers apply skills acquired over many years of in-house corporate and law firm experience to offer knowledgeable, practical and actionable advice.  

We counsel clients to understand that regulatory compliance, and associated risks, must be managed in two ways: being prepared ahead of time to best prevent problems; and, when problems do arise, being ready to effectively address them. Written procedures, careful documentation and detailed regulatory contractual provisions are often keys to regulatory success. These are areas in which we excel.

Services include:

Regulatory (with focus on life sciences)

Pre-Market

  • Assess business plans
  • Evaluate applicability of laws, regulations and policies to products and situations
  • Review product applications and strategies
  • Evaluate advertising and promotion campaigns and materials
  • Conduct due diligence regarding regulatory issues
  • Assess and draft compliant policies and procedures e.g., adverse event reporting, complaint handling, inspections
  • Draft and negotiate agreements with research partners, contract research organizations, federal agencies and others
  • Assist and respond to government correspondence
  • Provide hands-on training on regulatory issues

Post-Market

  • Continue to assess and advise on regulatory issues associated with business strategies
  • Provide product recall advice
  • Conduct adverse event analysis and reporting
  • Modify policies and procedures to fit changing regulatory requirements and company circumstances
  • Evaluate advertising and promotion campaigns and materials
  • Draft and negotiate contracts with collaborators, vendors, business partners, research organizations and others
  • Provide crisis management services including communications to government agencies and the public
  • Assist and respond to government correspondence
  • Provide hands-on training on regulatory issues

 Corporate Compliance

  • Cooperatively assist with compliance planning
  • Assess and draft policies and procedures
  • Conduct internal audits and investigations
  • Assist with crisis management
  • Provide hands on training about diverse compliance, enforcement and legal topics