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Newsletter

Issue 1 Vol. 1 August 2007
Open House Overview
building pic  Safis Solutions graduated from the Indiana University Emerging Technology Center (IUETC) earlier in the summer.  In celebration, we invited many clients, business partners, and colleagues to share this exciting time with us in our new office located at 342 Massachusetts Avenue, suite 402. 
 
The open house was a great success.  Over 80 people stopped by for appetizers, socializing, and networking.  We had a drawing for several Starbucks gift cards and two winners received 1 hour of regulatory consulting.  If you were not able to make it to the open house, please feel free to set up time to stop by and see the new office.
Innovention 2007
This was our first year to exhibit at Indiana Health Industry Forum's (ihif.org) Innovention.  We enjoyed a successful showing at our exhibit booth.   The two-day event was filled with networking, breakout sessions, poster sessions, and exhibits.
 
Kristin Jones, Vice President of Business Development for IHIF, reported that the event attracted approximately 350 attendees over the 2-day conference.  The partnership with the IBJ to host the Power Breakfast was also a great success.
Safis welcomes Diana Caldwell
Photo of Diana Caldwell
 
Safis recently brought Diana Caldwell on staff as Director of Sales and Marketing.  Caldwell joins Safis from Eli Lilly & Co. where she worked for over 15 years in sales and marketing leadership positions.  Her career experiences include sales, brand management, market research, and eMarketing management roles.
 
"We've recently expanded the management team because we have grown quite a bit since our inception," said Ping Poulsen, President & CEO.
Upcoming Events
August 2007
 
Safis Solutions is co-sponsoring a symposium at Purdue University's Discovery Park entitled "Research Translations: Planning for What Lies Ahead."  The day-long event is today, August 28th.  Gretchen Bowker, Safis Solutions, will present an overview of the FDA guidelines and discuss regulatory processes for devices and drugs.  More information can be found at the Purdue University website.
 
September 2007
 
Safis has been chosen as one of three companies to present at the Greater Indianapolis Chamber of Commerce's new Slingshot event.  The first Slingshot event will be held September 14th and focuses on the life science industry.   This invitation only gathering is designed to provide an opportunity for emerging businesses to showcase their products and services to business leaders.  For more information, visit the Chamber's website.
 
Gretchen Bowker will also be attending the RAPS 2007 Annual Conference in Boston, Massachusetts at the Hynes Convention Center from Sept. 23-26.  She will be leading a roundtable discussion on Global CMC Strategies and sitting on an expert panel to discuss RAC exam preparation. 
 
October 2007
 
Safis will be providing the featured speaker for the upcoming Indiana Biomedical Entrepreneurial Network's (IBEN) October 9th meeting.  The topic will be Life Science regulatory strategies.  Visit the IBEN website for more information in the coming months. 
Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device and biotech companies worldwide to ensure health authority requirements are met.  Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, auditing, and post-market surveillance programs.  Let Safis Solutions help you excel in today's complex regulatory compliance environment.
 
In This Issue
Open House Overview
Innovention 2007
Safis Welcomes Diana Caldwell
Upcoming Events
Bio Corner
Photo of Gretchen Bowker
 
Gretchen Bowker
, M.S., RAC, is the Director of Regulatory Affairs and Compliance Services.  In her role, she provides expertise for global regulatory affairs strategies and GXP compliance.  Bowker has over 20 years experience in life science product development in both start up and large pharmaceutical and device companies. She frequenlty speaks in training courses for international organizations such as ISPE and RAPS. 
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