We work harder and smarter with you.
Frestedt Incorporated provides services for drugs, biologics and devices.
Alimentix provides services for foods, food ingredients and dietary supplements.
Frestedt Learning Center offers customized training events.
Resources to help build a stronger science-based community.
Small but mighty.
Frestedt Incorporated is making news.

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

Blue circular graphic with Frestedt logo and CQRE sections
Green circular graphic with Alimentix logo and CQRE sections
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.

Featured Webinar:

Growing Need for Clinical Data Device PMCF Plans and Registries

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Client Testimonials

We are very happy with the support you and your team provided in selecting a vendor to fit our needs. We would not be at this point without you!
PROGRAM DIRECTORLARGE ACADEMIC CENTER IMAGING CORE LAB
It was great … This would have been a nearly impossible lift without their services.
SCIENTIFIC DIRECTORLARGE CORE IMAGING LAB
I appreciated the thoroughness of Frestedt's approach. We knew that everything was good before it was in the FDA's hands. Document assembly and presentation was very professional.
CHIEF MEDICAL OFFICERSMALL BIOPHARMA ONCOLOGY COMPANY
Wish we could have worked with you longer! You guys were great!!! Would 100% recommend you!
CLINICAL RESEARCH COORDINATORACADEMIC CLINICAL TRIAL SITE
Thank you for your expertise and guidance through a new clinical evaluation process
VP QUALITY ASSURANCEMID-SIZED DEVICE MANUFACTURER
Great team to work with.
VICE PRESIDENT, CORPORATE REGULATORY/QUALITYLARGE MEDICAL DEVICE MANUFACTURER
Well done project in challenging time.
PRINCIPAL REGULATORY AFFAIRS SPECIALISTLARGE MEDICAL DEVICE MANUFACTURER
Great company. Their work is excellent and the reports are fantastic.
CHIEF MEDICAL OFFICERMEDICAL DEVICE AND SOFTWARE SOLUTIONS COMPANY
"As experts in risk based monitoring, the Frestedt Inc team effectively negotiated a monitoring plan with our IRB to lift a hold on the study and manage a difficult site. Their risk based monitoring approach helped contain costs and get the study back on track for completion. I look forward to working with them again."
CEOPHARMACEUTICAL COMPANY
"This group is a fantastic group to work with. They are extremely knowledgeable, diligent and professional."
PRODUCT MANAGERMEDICAL DEVICE COMPANY
"This is science and sharing ideas at its best. #togetherwewin #wecandothis"
CO-FOUNDERMEDICAL DEVICE COMPANY
Dr. Frestedt’s understanding of these clinical risk documents is excellent and she has hired a very experienced team. Moreover, they have a lot of experience with Notified Bodies which enables them to help clients understand the best and most efficient ways to prepare their documents. I have complete confidence in Dr. Frestedt and her team to produce excellent documents and she is a wonderful teacher which is much appreciated.
VICE PRESIDENT, CLINICAL AFFAIRSMEDICAL DEVICE AND SOFTWARE SOLUTIONS COMPANY
Excellent work. Great organization. Will work with you to complete this project. Thank you.
FOUNDERSTART-UP MEDICAL DEVICE COMPANY
Really like the depth of knowledge, organization and ability to understand clients’ projects.
VICE PRESIDENT OF CLINICAL AFFAIRSMEDICAL DEVICE COMPANY
I would recommend this group’s services due to their knowledge base, work ethic and professionalism..
PRODUCT MANAGERMEDICAL DEVICE COMPANY
They [your competitor] took more time, and did not take as much responsibility for the project or content decisions. Your comfort with making decision and suggestions made working with you easier because we didn’t know what we wanted …that’s why we hired someone in the first place.
MANAGER OF CLINICAL OPERATIONSMEDICAL DEVICE COMPANY
It was a great course and Dr. Joy Frestedt was a very engaging and knowledgeable speaker. Highly recommend!
CLINICAL AFFAIRS SPECIALISTLARGE DEVICE COMPANY
Great job. I was a pleasure working with you.
R&D SENIOR MANAGERDIETARY SUPPLEMENT MANUFACTURER
Feedback has been incredibly valuable to see things more broadly and provide feedback to our European group.
CHIEF MEDICAL OFFICERMEDICAL TECHNOLOGY COMPANY
It was a pleasure working with you and your team yesterday…I look forward to working with you more in the future and building a strong working relationship. Thanks again!
DIRECTOR OF QUALITYNUTRITION COMPANY
Thanks Joy…your group is the best! I recommend you to everyone I know. Thanks again for being so responsive.
REGULATORY AFFAIRS MANAGER GLOBAL TECHNOLOGY COMPANY
I was impressed by how Frestedt Incorporated handled our audit, as well as their knowledge of ISO 13485:2016.
VICE PRESIDENT REGULATORY AFFAIRSMEDICAL DEVICE COMPANY
That is the record for fastest execution of a document in my professional experience!
PRINCIPAL SCIENTISTHEALTH AND NUTRITION COMPANY
That was a great session!
Conference Organizer
The speakers were all very well prepared and this made my ADHD mind very happy and engaged. I learned more here than I did nearly the entire conference.
Conference Attendee

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Certificates​

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

Google Reviews

Please rate and review us on Google!

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Tim Meyer
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
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
Great company. Their work is excellent and the reports are fantastic.