Graematter Unveils New IT System in Boston

Graematter™ today announced the formal commercial release of SOFIE™, a unique, patented regulatory intelligence system.  The SOFIE System is revolutionizing regulatory intelligence by integrating information from many government sources.  The vast amount of government data makes it difficult to locate and understand regulatory requirements.  The advanced search capabilities in SOFIE make it easier to find relevant and complete documentation.  The initial module focuses on the regulatory information generated by the Food and Drug Administration for medical devices.   Phase II will expand SOFIE further to include pharmaceutical information.

Regulatory Professionals guide their companies through complex regulatory requirements.  Locating, analyzing, and understanding this information is critical, especially for medical product companies.  With the SOFIE System, a single search can instantly produce the related and relevant documentation that would normally require hours to locate.  That is more important than ever as the amount of government information and the number of information sites is expanding at a rapid rate. 

“Regulatory professionals using the system tell us that they find what they need in a fraction of the time,” said Melissa Walker, the Founder, President and CTO of Graematter.  “More importantly, they have found critical documents that they might have otherwise missed by just going to typical sources.  In addition, SOFIE retains documents forever, even after the FDA removes them from their websites.” 

“We believe that Graematter is at the forefront of a new wave in managing government information,” said Merle Symes, Graematter CEO.  “The Federal Government prompted this in 2009 with an initiative for improved interoperability and openness of government information.  The SOFIE System by Graematter plays an integral role in their vision to make government information more available to entrepreneurs who can then find ways to make it more useful and beneficial for the general public.  Being able to find the right precedent regulatory documents is essential to developing the safest, shortest and lowest cost regulatory pathway for bringing life-saving and quality-of-life-enhancing products to patients.”  

Graematter is headquartered in St. Louis and plans to more than double staffing in the first year as it ramps up revenues and increases services.  “We plan to make St. Louis a hub of regulatory expertise,” said Walker.  “We believe that this will serve as a nice complement to the medical and life sciences centers of excellence that have been created in this region.”