GHP September 2016

46 | ghp September 2016 Regulation & Policy First Call for Help How would you define your client base? Frestedt Incorporated’s clients include some of the largest and smallest companies in the world. The firm’s client mix changes from month to month. Pharmaceutical companies enjoy having Frestedt Incorporated team members writing their investigator brochures or integrated safety summaries. Due to the firm’s deep experience and extensive knowledge, device companies call on Frestedt Incorporated staff frequently to author, develop and provide training on Clinical Evaluation Reports (CERs) and food compa- nies call for help on the claim substantiation records. While Notified Body positions on CE marking and CERs are constantly evolving, Frestedt Incorporated helps clients become more tactical by providing the most current, pragmatic solutions to meet Notified Body inspections with confidence. The firm also has a wholly owned subsidiary, Alimentix, with a special focus on running clinical trials for food companies (in- cluding those with new dietary ingredients or dietary supplements). Alimentix has convened GRAS (Gener- ally Recognized as Safe) panels which are responsive to the changing US FDA regulations (a new Final Rule was just released in August 2016). Frestedt Incorporated expanded operations in 2016 and the firm has begun assisting clients with test method validations and risk management assess- ments to support biomedical engineering efforts. What makes your firm unique? Frestedt Incorporated is unique due to the skill level of the team and the ability to meet tight timelines and budgets, with a focus on training the firm’s clients to do the work on their own, if they wish. Frestedt Incorporated staff members do not fear collaboration and sharing knowledge, indeed, the team focuses on working with good people on good projects using good processes. Frestedt Incorporated believes in building a stronger science community and working hard to help exactly as needed. The firm specializes in addressing the obvious as well as the not so obvious problems in real time. What are the major challenges facing your business at present? Significant change is underway globally for all facets of the research and development functions in every biomedical sector. Staying on top of the new information and knowing how to implement change within companies is not easy. From new international standards to changing regulations in most parts of the world, Frestedt Incorporated team members face these challenges together with their clients. The firm’s clients come back over and over as change and the need for expert, efficient technical support do not seem to slow down. Looking ahead, what is the main objective for your business? Frestedt Incorporated’s main objective is to serve the firm’s clients with the best possible science and to grow slowly while addressing this main objective. The firm will • Design and run a clinical trial; • Monitor or audit clinical trials run by others; • Develop a regulatory strategy to get a product to market; • Create regulatory documents to support product development” and • “Develop or expand a client Quality Management System to meet enterprise needs Frestedt Incorporated serves their clients as their ‘First call for help’, when- ever they need clinical, regulatory, quality or biomedical engineering sup- port. From running, monitoring or auditing a clinical trial, to negotiating difficult regulatory discussions within a company or with regulatory authori- ties around the world, they provide detailed and highly technical responses to meet specific needs. Frestedt Incorporated works for companies of all sizes including drug, device and food companies. They are known for their quick response times and low costs. As a small group of professionals with a large network of more than 70 consultants, they can address most problems quickly and efficiently. The firm’s CEO and President Dr. Joy Frestedt reveals more, including her thoughts on negotiating difficult regulatory decisions, running clinical trials for food companies and how significant changes are on the horizon for all facets of research and development in the biomedical sector. LI160015