A U.S agent acts as a liaison between your company and the FDA. The agent is responsible for ensuring compliance with the FDA's rules and regulations and for answering any questions or requests that may come from the FDA. A U.S. agent must reside or conduct business in the US to be available during office hours.
How we help
The SDS group, consisting of SDS Life Science and SDS MedteQ, can support with the following:
- Customized regulatory strategy and guidance
- Efficient preparation of regulatory documentation
- Compilation and submission of regulatory applications
- Managing the regulatory processes until opinion
- Dedicated representation during FDA meetings
How to begin? A first meeting is a good start 👇
