About Frestedt Incorporated

As time has gone by, Frestedt Incorporated continues to strengthen our differentiation in the marketplace. We are known for our high-quality products and services. We specialize in work across silos and translating languages from clinical to regulatory to quality to engineering. We understand when a drug can be a single molecular entity or must be considered a biologic or botanical; we know when a medical device needs to be considered a combination product and when clinical data is required for device clearance or approval; and we have experience supporting the science behind foods to prevent a food from becoming a drug in the United States. We understand the importance of marketing claims and the limitations required by the regulations.

As global regulatory requirements become increasingly complex and as the integration of safety, efficacy and performance across all silos comes more into focus, Frestedt Incorporated helps with immediate project solutions and long-term training and quality system developments. Working at senior management levels within pharmaceutical, device and food companies keeps Frestedt Incorporated at the forefront of clinical research, regulatory negotiations, quality solutions and biomedical engineering services. Our expertise may help you to navigate well-known pathways quickly and efficiently or Frestedt Incorporated may help to blaze a new path through a completely uncharted territory. Either way and from start to finish, Frestedt Incorporated can help your team stay on the path to product launch while maintaining clinical, quality, regulatory and ethical engineering compliance.