Frestedt
Frestedt Incorporated is a comprehensive provider of clinical, regulatory, quality, and engineering services for the biotech, pharmaceutical, medical device, and food industries. They focus on supporting innovation through expert project management, regulatory strategy, clinical trials, quality systems, biomedical engineering, and training, aiming to be an extension of their clients' teams with high-quality, ethical, and efficient solutions.
Industries
Nr. of Employees
medium (51-250)
Products
Technical publications and presentation materials
Books, conference presentations, downloadable training slides and white papers addressing clinical, regulatory and quality topics.
Technical publications and presentation materials
Books, conference presentations, downloadable training slides and white papers addressing clinical, regulatory and quality topics.
Services
End-to-end clinical trial support including protocol development, site selection, monitoring, data management, biostatistics and final study reporting.
Regulatory strategy development, preparation of submission dossiers (IND, IDE, NDA, PMA, 510(k) etc.), regulatory authority meeting preparation and correspondence.
Develop QMS components (quality manuals, SOPs, work instructions, forms) and provide training, audits and gap remediation to meet regulatory and standard requirements.
Create design history files, develop verification/validation strategies, conduct process validations and support labeling/IFU engineering reviews.
Customizable remote and on-site training programs covering clinical operations, regulatory submissions, GCP, ISO standards, medical writing and CER preparation.
Design and conduct clinical trials and literature-based substantiation for foods, ingredients, dietary supplements and low-risk products, including customized diets and nutrition counseling.
End-to-end clinical trial support including protocol development, site selection, monitoring, data management, biostatistics and final study reporting.
Regulatory strategy development, preparation of submission dossiers (IND, IDE, NDA, PMA, 510(k) etc.), regulatory authority meeting preparation and correspondence.
Develop QMS components (quality manuals, SOPs, work instructions, forms) and provide training, audits and gap remediation to meet regulatory and standard requirements.
Create design history files, develop verification/validation strategies, conduct process validations and support labeling/IFU engineering reviews.
Customizable remote and on-site training programs covering clinical operations, regulatory submissions, GCP, ISO standards, medical writing and CER preparation.
Design and conduct clinical trials and literature-based substantiation for foods, ingredients, dietary supplements and low-risk products, including customized diets and nutrition counseling.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Quality management systems (QMS) and ISO compliance
- Biomedical engineering and device documentation
Key Technologies
- Protocol design and clinical trial methodologies
- Risk-based monitoring
- Biostatistics and clinical data management
- Regulatory submission formats (CTD/eCTD)
News & Updates
Frestedt Incorporated received the Best of Minneapolis Award for Research Institute for the 6th consecutive year, highlighting their dedication and excellence.
Joy Frestedt, PhD, has been added to the advisory board of United Science, a manufacturer of supercritical CO2 extraction equipment.
Frestedt Incorporated announced the addition of Dr. Christopher Barkley, PhD in Linguistics and Cognitive Sciences, to their team.
Announcement of the growth of Frestedt with the addition of Dr. Christopher Barkley.
Frestedt Incorporated was awarded the 2019 CRO Company of the Year by Pharma Tech Outlook.
Frestedt Incorporated received the Best of Minneapolis Award for 2020.
Frestedt Incorporated received the Best of Minneapolis Award for Research Institute for the 6th consecutive year, highlighting their dedication and excellence.
Joy Frestedt, PhD, has been added to the advisory board of United Science, a manufacturer of supercritical CO2 extraction equipment.
Frestedt Incorporated announced the addition of Dr. Christopher Barkley, PhD in Linguistics and Cognitive Sciences, to their team.
Announcement of the growth of Frestedt with the addition of Dr. Christopher Barkley.
Frestedt Incorporated was awarded the 2019 CRO Company of the Year by Pharma Tech Outlook.
Frestedt Incorporated received the Best of Minneapolis Award for 2020.