About Frestedt Incorporated
We work harder and smarter with you.
Frestedt Incorporated uses an innovative, virtual process to keep our service quality of the highest caliber and our timelines and costs as low as possible. The Frestedt Incorporated team is a dynamic partner. We run clinical trials, negotiate with regulatory authorities, build quality systems and provide biomedical engineering solutions. Frestedt Incorporated is the parent company for Alimentix and the Frestedt Learning Center. If you need help, please call us.
We understand science and we work hard,
so you don’t have to!
To continually improve and support clinical, regulatory, quality and engineering affairs to meet client requirements and to adhere to strong business ethics.
To be an integrated extension of each client offering hands-on experience to meet specific needs and to bring projects to life; on time, on budget and on target.
To provide products and services designed to meet or exceed customer requirements in pharmaceutical, medical device, food and biotechnology industries in compliance with current regulations, applicable standards, good practices and specifications.
Founded on February 26, 2008, Frestedt Incorporated provides exquisitely targeted clinical, regulatory, quality and engineering system solutions. We moved into our corporate offices in 2011, expanded our team members and contracted to a virtual workforce again in 2021. Over the first 13 years of operation, we have served some of the largest and smallest companies in the world and we have provided services to many academic centers, clinical research organizations, and various science groups.
Frestedt Incorporated employs and contracts experts in clinical, regulatory, quality and engineering to address client needs. This staffing model allows Frestedt Incorporated to manage any size of project while working as an extension of your team.
We focus on the entire product development life cycle for pharmaceuticals and biologics, medical devices and in vitro diagnostics as well as foods, ingredients, dietary supplements and natural products.
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.
Awarded To: Frestedt Incorporated
Awarded by: Minneapolis Award Program
Awarded To: Pamela Wolfe
Awarded by: Association of Clinical Research Professionals