Frestedt Incorporated provides clinical, regulatory, quality and biomedical engineering expertise for biotechnology, pharmaceutical and medical device industries. Alimentix provides food-related support. Both Frestedt Incorporated and Alimentix infuse training into all client projects, wherever needed and helpful. We deliver the best value for high-caliber, integrated services based on sound practical experience while working as an extension of your current team.

Frestedt Incorporated and Alimentix, working hand in hand to support and improve medical innovation

We understand the importance of working with qualified professionals to address your needs. Our staff works strategically on your projects when you don’t want an oversized CRO and we provide much more support than a single independent consultant. We draw upon our team of over 70 experts to deliver results quickly, efficiently and cost-effectively.

How we work

How we work is all about you.

Frestedt Incorporated builds our approach based on your needs. We are nimble, motivated and interactive. Our knowledgeable experts are carefully selected and brought together to get the project done to meet your goals, while complementing your capabilities.

We become part of your team – with your values.

Whether you are a sponsor, CRO or research site, we meet your needs by working creatively, collaboratively and efficiently as a strategic partner. We work on exactly what you need and we keep costs reasonable while producing a high quality, ethical result.

Our business model is designed to meet your needs.

We can help to develop your quality systems, get you geared up for a new regulatory submission, facilitate your current clinical research studies and orchestrate your biomedical engineering documents, strategies and changes.

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Growing Need for Clinical Data Device PMCF Plans and Registries

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Client Testimonials


National Women's Business Enterprise Certification
Women Owned Small Business Certification
TÜV SÜD America ISO 9001: 2015 Certificate
TÜV SÜD America ISO 9001: 2015
ISO 13485 Certified Lead Auditor Certificate
ISO 13485 Certified Lead Auditor
Tim Meyer
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Frestedt Incorporated is an exceptional company in the clinical space. Dr Frestedt has expertise in many areas, especially in clinical risk. I have been very impressed with their approach to clinical risk documents as they have a very good …
Linnea Schmidt
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Breadth of knowledge and experience in clinical, regulatory and quality affairs. Frestedt Inc. can provide expertise on a wide variety of projects and produces on-time, quality outputs.
Robin Germany
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Great company. Their work is excellent and the reports are fantastic.