We specialize in counseling pharmaceutical and medical technology makers.

Gardner Law represents pharmaceutical, medical device, diagnostic, digital health, biotechnology, and laboratory companies across the United States.

Meet the Team

Gardner Law counsels clients on laws and regulations that impact the promotion, manufacturing, and development of regulated products. We advise companies on product approvals, clinical studies, commercialization, manufacturing, and corrective actions, such as addressing Warning Letters and performing recalls.

Representative matters include:

  • Outsourced compliance management
  • Serving on promotional and scientific review (Medical, Legal, Regulatory) teams
  • Seeking product approval for clients
  • Training
  • Compliance audits and investigations
  • Designing and implementing compliance programs
  • Responding to regulators and competitors
  • Negotiating with the government
  • Performing regulatory assessments
  • Making FDA submissions
  • QMS services and remediation
  • Privacy

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