In October 2022, SDS Life Science and SDS MedteQ were acquired by the American company Cytel Inc (press release). The acquisition opened the possibility of acting as an agent for pharmaceutical and medical technology companies outside the United States. With Cytel also comes a strategic consulting team with extensive collective experience from the American market, where many have worked within the FDA's various divisions.
"Our customers have a strong focus on the U.S. market, and with the experience we already have of the regulatory landscape in the U.S., this is a natural next step for us," says Erika Spens, Head of Regulatory Affairs SDS Life Science.
In the past, the SDS companies have used external agents in contact with the FDA, which is no longer required.
"Being able to act as a U.S. agent provides substantial value for many of our clients," says Maria Lundberg, CEO of SDS Life Science. "We look forward to strengthening our presence in the U.S. with our colleagues at Cytel."
What is a U.S. Agent (FDA Agent)?
A foreign company appoints an FDA representative to handle communications with the FDA in the United States. The agent is responsible for ensuring that the company complies with the FDA's rules and regulations and answering any questions or requirements from the FDA. An FDA representative must reside or conduct business in the United States to be available during office hours.
