Frestedt Incorporated

Frestedt Incorporated is a virtual consulting firm founded in 2008 that provides clinical, regulatory, quality, and biomedical engineering services for the biotechnology, pharmaceutical, medical device, and in vitro diagnostics industries. The company operates with a team of over 70 experts and maintains ISO 9001 certification and ISO 13485 Certified Lead Auditor credentials.

The firm's service model positions consultants as extensions of client teams, offering specialized expertise in clinical trial management, regulatory submissions (including INDs), quality system development, and biomedical engineering documentation. Frestedt operates two subsidiaries: Alimentix, which serves the food, ingredient, and dietary supplement sectors, and the Frestedt Learning Center, which provides customized training programs.

The company has received multiple industry recognitions, including being named CRO Company of the Year by Pharma Tech Outlook in 2019 and Best for Biotechnology Clinical Research in Minnesota by Global Health & Pharma in 2016. Client testimonials emphasize the firm's collaborative approach, ability to work efficiently with smaller organizations, and expertise in navigating complex regulatory requirements across pharmaceutical, device, and combination product pathways.

Choose Frestedt Incorporated when you need senior-level regulatory and clinical expertise integrated directly into your team without the overhead of a large CRO. The firm excels in scenarios requiring deep regulatory knowledge, such as preparing IND applications, developing clinical evaluation reports for medical devices, or establishing quality systems compliant with ISO 13485.

Expect a collaborative engagement model where consultants function as team extensions rather than external vendors. The firm's strength lies in translating complex regulatory requirements into practical implementation strategies, particularly valuable for smaller organizations or those navigating novel regulatory pathways.

Frestedt Incorporated focuses exclusively on regulated healthcare product development across pharmaceuticals, biologics, medical devices, and in vitro diagnostics. The firm's healthcare expertise centers on FDA regulatory submissions, clinical trial management, ISO 13485 quality systems, and international regulatory compliance including work with Notified Bodies for CE marking.

Through its Alimentix subsidiary, the company extends its regulatory expertise to dietary supplements and functional foods, addressing the unique intersection of food and drug regulations. This specialized focus on life sciences regulatory affairs differentiates Frestedt from general healthcare IT or digital health consultancies.

The ideal client is a small to mid-sized biotechnology, pharmaceutical, or medical device company developing innovative products that require sophisticated regulatory strategy and clinical development expertise. Companies seeking consultants who will deeply integrate with their team, provide hands-on execution rather than just advice, and can navigate both FDA and international regulatory pathways will find the best fit with Frestedt's model.