Last modified: Tuesday, June 5, 2007
IUETC business helps life sciences companies comply with FDA regulations
FOR IMMEDIATE RELEASE
June 5, 2007
BLOOMINGTON, Ind. -- Navigating complex U.S. Food and Drug Administration regulations can be vexing for a young or understaffed pharmaceutical or medical device company. So it's fortunate Indiana life sciences companies can rely on locally owned Safis Solutions, LLC, for help.
Safis Solutions graduated from the Indiana University Emerging Technologies Center (IUETC) in late May. Mark Long, president and CEO of IUETC, said that this is only the fourth company nurtured to independence by the Indianapolis-based life sciences incubator. "We are proud of the growth and success Safis Solutions has shown over the past several years. They brought a much needed service to our incubator community."
"We've had an excellent relationship with the IUETC," said Ping Poulsen, Safis Solutions' president and CEO. "They provided us with business consulting opportunities and the IUETC's name lent our business some initial credibility. We were able to easily engage with potential clients within the facility and with others in the area. It's time for us to move out and become fully integrated into the greater Indianapolis community."
Safis Solutions was formed in 2002 by Poulsen, who was encouraged by friends and colleagues to start a consulting business that specializes in government policy compliance and quality assurance in the healthcare industry. Safis moved into the IUETC in 2004. Its operations have grown steadily since then, and its client base has become international in breadth.
Safis Solutions walks businesses through the verbal jungle of pharmaceutical drug and medical device compliance. Policies and regulations set forth by international government agencies such as the FDA can get complicated, Poulsen said, so her business clarifies compliance requirements to make life science business owners' lives easier.
Poulsen also said that Safis Solutions personnel help ensure that software and manufacturing systems used in companies meet compliance and quality assurance standards.
"We've grown quite a bit since our inception," Poulsen said. "We recently hired someone to oversee marketing, and we're expanding the sales team. We are currently pursuing new clients overseas as well as here in central Indiana."
Safis Solutions has opened its new offices in downtown Indianapolis at 342 Massachusetts Ave., Suite 402, 46204.