Regulatory Affairs Associates Provides U. of Michigan Pediatric Devices with FDA Support
Pontiac, MI, March 18, 2010 --(PR.com)-- Regulatory Affairs Associates (RAA) announced today that the company will provide FDA consulting services to the University of Michigan Pediatric Device Consortium (M-PED). The consortium is funded by a 2-year, $2 million dollar grant from the Food and Drug Administration and will promote commercialization of pediatric medical devices.
The grant was awarded to the Medical Innovation Center. Dr. James Geiger, Executive Director, and Brenda Jones, Managing Director, identified RAA as regulatory consultants for the Consortium.
Regulatory Affairs Associates is a leading FDA consulting firm specializing in both pharmaceutical and medical device guidance and consulting. Stephen Goldner, President and CEO of RAA, said: “We are elated to be working with such a storied institution as the University of Michigan. U of M is a leader in developing medical technology and innovative therapies. The M-PED project is a great example of this, and we are pleased to again lend our experience and knowledge to bring new pediatric devices to these precious patients.”
Ms. Jones, Managing Director of the Medical Innovation Center, said: “We brought industry leaders together into a medical device development ecosystem. This will overcome hurdles associated with the commercialization of pediatric devices. Regulatory Affairs Associates brings the expert knowledge base and credentials to improve the success of pediatric device regulatory approval. They will support our scientists and inventors with critical regulatory advice thereby moving new pediatric devices to market.”
About Regulatory Affairs Associates
Regulatory Affairs Associates is a full service drug and medical device firm providing expert FDA consulting services for companies, inventors and universities worldwide. Their experts have worked over 35 years to bring many life sustaining drugs and medical devices to the marketplace in the USA and around the world. For more information, visit www.regaffairs.net .
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The grant was awarded to the Medical Innovation Center. Dr. James Geiger, Executive Director, and Brenda Jones, Managing Director, identified RAA as regulatory consultants for the Consortium.
Regulatory Affairs Associates is a leading FDA consulting firm specializing in both pharmaceutical and medical device guidance and consulting. Stephen Goldner, President and CEO of RAA, said: “We are elated to be working with such a storied institution as the University of Michigan. U of M is a leader in developing medical technology and innovative therapies. The M-PED project is a great example of this, and we are pleased to again lend our experience and knowledge to bring new pediatric devices to these precious patients.”
Ms. Jones, Managing Director of the Medical Innovation Center, said: “We brought industry leaders together into a medical device development ecosystem. This will overcome hurdles associated with the commercialization of pediatric devices. Regulatory Affairs Associates brings the expert knowledge base and credentials to improve the success of pediatric device regulatory approval. They will support our scientists and inventors with critical regulatory advice thereby moving new pediatric devices to market.”
About Regulatory Affairs Associates
Regulatory Affairs Associates is a full service drug and medical device firm providing expert FDA consulting services for companies, inventors and universities worldwide. Their experts have worked over 35 years to bring many life sustaining drugs and medical devices to the marketplace in the USA and around the world. For more information, visit www.regaffairs.net .
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Regulatory Affairs Associates
Stephen Goldner
248 747 8008
www.regaffairs.net
Stephen Goldner
248 747 8008
www.regaffairs.net
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