Compliance Counseling - FDA
Our team works proactively with clients in various jurisdictions to ensure compliance with diverse applicable regulations and guidelines. With experience in over 20 countries, clients seek our assistance and advice on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Quality System Regulation (QSR) matters. We support manufacturers in designing and implementing comprehensive compliance programs, and in handling sensitive internal investigations of compliance matters.
The PhRMA Code of Conduct and OIG Guidance, as well as recent government Settlement and CIAs, placed increased emphasis on proactive compliance activities. Our group works with manufacturers to design and implement comprehensive compliance programs in order to avoid improper activities and enforcement action.
We have drafted FDA, healthcare and privacy compliance documents including Codes of Conduct and Policies and Procedures, as well as more handy Field Guides for sales personnel on the move. These documents covered the key risk areas our clients manage day to day, including: educational grants, advisory boards and consultant meetings, charitable donations, promotional activity, research and clinical trials, business meals and gifts, continuing medical education, displays and exhibits, investigator-initiated grants, promotional speaker programs, publication activities, medical science liaisons and related state requirements.
We work with companies worldwide to develop comprehensive FDA, healthcare and privacy compliance training programs, covering:
- Mandatory basic and specific training as required by Corporate Integrity Agreements
- Hands-on training for sales and marketing personnel
- Training modules intended to reinforce specific training objectives
We also assist in-house counsel and compliance officers in responding to compliance issues from internal clients, such as grant committees, sales and marketing personnel, regulatory affairs, medical education/medical affairs and clinical affairs. In particular, we advise on:
- Reviewing and approving educational and research grants
- Structuring advisory boards
- Retaining consultants
- Reviewing and approving advertising and promotional practices
In addition, we handle numerous sensitive internal investigations of compliance matters, including issues raised in confidential hotline phone calls, and provide independent review and analysis of alleged violations.