MCRM Announces Affiliation with Regulatory Affairs Associates Firms, Brings Regulatory Services to New Plymouth Township Facility
At the groundbreaking for the Michigan Center for Regenerative Medicine (MCRM), a magnet facility for adult stem-cell research, manufacturing and commercialization, it was announced that Regulatory Affairs Associates is joining the facility as a partner when the facility construction is completed.
Plymouth Township, MI, October 27, 2010 --(PR.com)-- At the groundbreaking for the Michigan Center for Regenerative Medicine (MCRM), a magnet facility for adult stem-cell research, manufacturing and commercialization, it was announced that Regulatory Affairs Associates is joining the facility as a partner when the facility construction is completed.
Regulatory Affairs Associates (RAA) specializes in providing invention to approval regulatory consulting in toxicology, formulation, clinical trial management, manufacturing, engineering, and business planning. Their services cover a wide variety of therapeutics including oncology, anti-viral, anti-infective, gastroenterology, hematology, cardiovascular and dermatology.
“The Michigan Center for Regenerative Medicine is poised to become a world class facility that will serve the same constituency as Regulatory Affairs Associates, the up and coming technologies that will change the way we treat illness,” said Stephen Goldner, President and CEO of RAA. “We are excited to work with the MCRM and its future tenants to guide their promising therapies through the FDA approval process and beyond.”
In addition to the partnership with MCRM, RAA recently was awarded two contracts from the National Cancer Institute (NCI) to assist with new SBIR development projects. The contracts cover both drug development and medical devices-test kits, both of which use stem cell technology. The experts at RAA are embarking on this process to help companies from around the country meet the testing and data requirements of the FDA in order to become a treatment options for patients and physicians. These contracts will result in companies from around the country who have received NCI awards traveling to the Wayne County to meet with RAA and develop their FDA strategy, providing more exposure to the resources of our region while helping develop break-through drug research.
“Regulatory Affairs Associates is an exemplary organization that provides expert services to companies at all phases of the approval process,” said Jim Richer, member of the Board of Directors for MCRM. “Being able to offer regulatory assistance has always been a long term goal, and housing the offices of RAA and MCRM allows us to have on-site regulatory consulting from day one for our future tenants. We look forward to working together to further expand the medical breakthroughs being developed in the University Research Corridor and help bring these inventions to market.”
When completed, the Michigan Center for Regenerative Medicine will be a 22,000+ square foot, state-of-the-art facility housing research and development, manufacturing, and commercialization affiliates of adult stem-cell, regenerative medicine. Included in the foot print will be 2,600 square feet dedicated to Good Manufacturing Practice / Current Good Tissue Practice facility for human stem cell propagation and stem cell device fabrication, storage and shipping.
For more information on MCRM, please contact Jim Richter at 734-353-4398 or via email at jarichter@michresearch.org. If you would like additional information on Regulatory Affairs Associates, please contact Stephen Goldner at 248-747-8008 or sgoldner@regaffairs.net
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Regulatory Affairs Associates (RAA) specializes in providing invention to approval regulatory consulting in toxicology, formulation, clinical trial management, manufacturing, engineering, and business planning. Their services cover a wide variety of therapeutics including oncology, anti-viral, anti-infective, gastroenterology, hematology, cardiovascular and dermatology.
“The Michigan Center for Regenerative Medicine is poised to become a world class facility that will serve the same constituency as Regulatory Affairs Associates, the up and coming technologies that will change the way we treat illness,” said Stephen Goldner, President and CEO of RAA. “We are excited to work with the MCRM and its future tenants to guide their promising therapies through the FDA approval process and beyond.”
In addition to the partnership with MCRM, RAA recently was awarded two contracts from the National Cancer Institute (NCI) to assist with new SBIR development projects. The contracts cover both drug development and medical devices-test kits, both of which use stem cell technology. The experts at RAA are embarking on this process to help companies from around the country meet the testing and data requirements of the FDA in order to become a treatment options for patients and physicians. These contracts will result in companies from around the country who have received NCI awards traveling to the Wayne County to meet with RAA and develop their FDA strategy, providing more exposure to the resources of our region while helping develop break-through drug research.
“Regulatory Affairs Associates is an exemplary organization that provides expert services to companies at all phases of the approval process,” said Jim Richer, member of the Board of Directors for MCRM. “Being able to offer regulatory assistance has always been a long term goal, and housing the offices of RAA and MCRM allows us to have on-site regulatory consulting from day one for our future tenants. We look forward to working together to further expand the medical breakthroughs being developed in the University Research Corridor and help bring these inventions to market.”
When completed, the Michigan Center for Regenerative Medicine will be a 22,000+ square foot, state-of-the-art facility housing research and development, manufacturing, and commercialization affiliates of adult stem-cell, regenerative medicine. Included in the foot print will be 2,600 square feet dedicated to Good Manufacturing Practice / Current Good Tissue Practice facility for human stem cell propagation and stem cell device fabrication, storage and shipping.
For more information on MCRM, please contact Jim Richter at 734-353-4398 or via email at jarichter@michresearch.org. If you would like additional information on Regulatory Affairs Associates, please contact Stephen Goldner at 248-747-8008 or sgoldner@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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