Regulatory Agency Communication/Interaction
The ability to communicate concisely and effectively is an important tool in the pursuit of your goals.
Often situations arise where the best course of action is a one-on-one meeting with FDA and/or other Regulatory bodies. QualityHub will partner with you and your team during meetings with FDA at their District Offices or at Headquarters, or at any other Regulatory body location worldwide.
Our extensive experience with FDA and Regulatory bodies can be leveraged to help you prepare for meetings, craft the right message, and answer FDA’s questions, as necessary. We provide support in the following areas:
- Assisting with Strategies
- Communicating with Regulatory agencies
- Communication and support for 483s, Recalls, Warning Letters, and Consent Decrees
- Assisting with FDA negotiations and appeals
- Providing verification to FDA and Regulatory bodies on client progress
- Acting as a FDA liaison for international and domestic clients
- Preparing FDA meeting requests and requisite briefing packages
- Performing “rehearsals” for FDA meetings using former FDA Compliance Managers
- Preparation and delivery of presentations to FDA and/or other Regulatory bodies
- Performing on-site regulatory assistance, and training related to Regulatory Interactions
- Provide guidance on the latest regulatory issues and requirements