Gardner Law only represents companies that are regulated by the FDA.
The firm serves medical device, pharmaceutical and combination product companies of all sizes, and also represents diagnostic, biologic, HCT/P, dietary supplement, food, cosmetic and product companies.
Gardner Law works with clients of all sizes, and with products from development through commercialization. The firm helps design, implement, and manage compliance programs that ensure business practices are compliant with FDA, fraud and abuse (anti-bribery and false claims), Sunshine, and privacy laws and regulations, plus OIG guidelines and AdvaMed and/or PhRMA codes.
The firm counsels clients on the regulations that impact the promotion, manufacturing, and development of regulated products. Gardner Law advises companies on product approvals, clinical studies, commercialization, manufacturing, and corrective actions, such as addressing Warning Letters and performing recalls.
Clients choose Gardner Law to:
- Conduct training programs that are tailored to their needs
- Manage internal investigations and compliance audits
- Perform due diligence for both buyers and sellers
- Implement Quality Management System remediation programs and improvements
- Make regulatory pathway assessments, and efficient, effective regulatory submissions (e.g., pre-market submissions for devices and drugs)
- Supporting the Compliance function
- Sitting on labeling and scientific material review committees
- Performing audits and investigations
- Resolving enforcement actions
- Drafting compliance policies and procedures
- Training staff
- Advising on laws, regulations, and guidances
- Making government submissions
- Detecting and remediating quality management system issues
- Performing due diligence for both buyers and sellers