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)
Frestedt
Minneapolis, Minnesota, United States, North America
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
Clinical research services
End-to-end clinical trial support including protocol development, site selection, monitoring, data management, biostatistics and final study reporting.
Regulatory support services
Regulatory strategy development, preparation of submission dossiers (IND, IDE, NDA, PMA, 510(k) etc.), regulatory authority meeting preparation and correspondence.
Quality management system development
Develop QMS components (quality manuals, SOPs, work instructions, forms) and provide training, audits and gap remediation to meet regulatory and standard requirements.
Biomedical engineering and testing support
Create design history files, develop verification/validation strategies, conduct process validations and support labeling/IFU engineering reviews.
Training and education (regulatory, clinical, quality)
Customizable remote and on-site training programs covering clinical operations, regulatory submissions, GCP, ISO standards, medical writing and CER preparation.
Food and dietary supplement clinical investigations
Design and conduct clinical trials and literature-based substantiation for foods, ingredients, dietary supplements and low-risk products, including customized diets and nutrition counseling.
Clinical research services
End-to-end clinical trial support including protocol development, site selection, monitoring, data management, biostatistics and final study reporting.
Regulatory support services
Regulatory strategy development, preparation of submission dossiers (IND, IDE, NDA, PMA, 510(k) etc.), regulatory authority meeting preparation and correspondence.
Quality management system development
Develop QMS components (quality manuals, SOPs, work instructions, forms) and provide training, audits and gap remediation to meet regulatory and standard requirements.
Biomedical engineering and testing support
Create design history files, develop verification/validation strategies, conduct process validations and support labeling/IFU engineering reviews.
Training and education (regulatory, clinical, quality)
Customizable remote and on-site training programs covering clinical operations, regulatory submissions, GCP, ISO standards, medical writing and CER preparation.
Food and dietary supplement clinical investigations
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)