We have extensive experience making FDA submissions, designing and administering Quality Management Systems, and remediating quality issues.
Read More >
We have extensive experience with clinical activities.
We regularly provide counsel regarding the impact of laws and regulations on Marketing, Sales, Health Economic/Market Access, Medical, and Clinical activities.
Gardner Law counsels clients on how to label, advertise, and promote FDA-regulated products.
Gardner Law represents clients dealing with FDA and DOJ enforcement actions.
The firm has extensive experience with new transparency requirements including the Physician Payments Sunshine Act (“Sunshine Act”) and state laws’ analogs.