Pamela Wolfe, MBA, MS, CCRP re-joins the team, Dr. Frestedt discusses CER needs for PMCF and many successful projects were completed in the first half of the year.
15NOV2017 St. Louis Park, MN– Frestedt Incorporated/Alimentix
Pamela Wolfe, MBA, MS, CCRP re-joined the company on 13NOV2017 bringing a breadth of knowledge with her. As a valued member of the team back in 2011-2012 as a Strategic Project Manager, she is welcomed back as a leader in this directorship role. With over ten years of experience in clinical trials, quality management systems, regulatory affairs, project management and operations; Pamela will be an in integral part of the variety of work that takes place at Frestedt Inc. / Alimentix. Pamela received her MS from Clemson University, her MBA from the University Of Minnesota- Carlson School Of Management, is a Certified Clinical Research Professional (CCRP) with the Society of Clinical Research Professionals (SoCRA) and serves on the Association of Clinical Research Professionals (ACRP) Board of Directors as the Minnesota Chapter Vice President. When Pamela is not at work, she enjoys attending Broadway shows, discovering new ice cream shops around the Twin Cities and solving puzzles.
Also, today, Dr. Frestedt presented a webinar in partnership with MakroCare about Post Market Clinical Follow-Up (PMCF) data entitled: “Growing Need of Clinical Data, PMCF & Registries for Devices.” This international audience included attendees from many of the world’s largest and smallest medical device companies.
Frestedt Inc. / Alimentix Q1 & Q2 Highlights
- Completed a series of Class III medical device regulatory submissions for a large international company (including global team training on CERs and labeling)
- Completed multiple CERs and a gap analysis to international standards for a large tissue device company
- Created multiple regulatory plans
- Conducted SOP trainings
- Conducted multiple CER training events (including full 2-day courses for multiple companies and institutions)
- Alimentix published a white paper on proteins, muscle synthesis and consumption
- Converted a large Design History File from 1980’s paper files to electronic for a global device company
- Alimentix published a peer-reviewed paper on clinical trial designs for foods http://austinpublishinggroup.com/nutrition-food-sciences/download.php?file=fulltext/ajnfs-v5-id1086.pdf
- Alimentix provided food naming regulatory guidance for a global food ingredient company
- Guided marketing in China for a medical device company
- Analyzed and documented safety signals and labeling for a safety call center
- Guided animal, veterinary and human IVD device for a small start-up company
- Conducted 2-day New Drug Application (NDA) course for a large, global medical technology company
- Provided 2-day training sessions on Investigational New Drug (IND) Applications
- Alimentix developed Investigational Brochure for large food ingredient company
- Provided 510(k) submission support to a small start-up company
At Frestedt Inc. / Alimentix, our work is our marketing. By providing high-quality and on-time deliverables exceeding expectations, we continue to grow with both new and repeat business by word of mouth. We want you to call us if you need assistance with clinical, regulatory, quality or engineering work. Spread the word, we are your first call for help!
About Frestedt Inc.
Frestedt Incorporated (www.frestedt.com) is an unparalleled consortium of over 70 knowledge experts working in an innovative, virtual setting to keep our service quality of the highest caliber and our costs as low as possible. The Frestedt Incorporated team works to solve problems with a forward-thinking approach designed to provide all deliverables within tight timelines and budgets. We are a dynamic partner, focused on providing exactly the right solution to meet our client’s needs and we hold ourselves to the highest standards in everything we do. We provide support in running clinical trials and negotiating with regulatory authorities, and we build quality systems and training sessions designed to secure the release of our client’s products and claims to the market. In addition, we also provide support in creating literature reviews and clinical evidence reports for your specific needs.
Alimentix (www.alimentix.com) is a comprehensive clinical investigation center (clinical trial site) dedicated to conducting clinical trials for foods, food ingredients, dietary supplements, natural products, over the counter pharmaceuticals, and non-significant risk medical device products.