Abstract: . . .  IVD, combination drug, and bioscience industries. Since our inception in 1999, RCRI has helped more than 150 companies worldwide, ranging from development stage start-ups to the largest Fortune 500 companies, translate their product plans into successful revenue generating business. Whether it is a single task or a complex multi-faceted project, you can count on the highly qualified professionals at RCRI. Please contact us to discuss how we can assist you.  . . .
. . .  management system. As part of RCRI’s quality processes, customer satisfaction surveys will be sent at each project milestone. Should you have comments regarding your experiences with RCRI, please contact Juli Stabile, Director of Business Development at jstabile@rcri-inc.com or 952-746-8080. ISO 9001 :2000 FM 89594 For more information on ISO certification, visit the ISO website at www. ISO .org . RCRI receives ISO 9001 :2000 certification Page 2 RCRI News May, 2005 New Appointments at RCRI RCRI is delighted to announce the appointments of Tito Aldape to Vice President of Regulatory Affairs and Quality Systems, Andy Anderson to Senior Regulatory Project Director, and Juli Stabile to Director of Business Development. Tito Aldape, MS Vice President of Regulatory Affairs & Quality Systems Tito Aldape . . .
. . .  responsible for which combination product(s). There is concern that the US FDA needs to apply a more consistent and predictable approach toward regulation and review of combination products. As such, RCRI participated in a Regulatory Affairs Professionals Society (RAPS) summit conference to explore regulation of combination products. A panel of senior regulatory executives, including an RCRI principal advisor, gathered input from participants. The summit’s panel and participants recommended that: FDA modify its intercenter agreements to more clearly delineate each center’s roles and responsibilities for handling (1) approvals of combination products, (2) modifications to existing combination products and (3) labeling review; Greater predictability from the process of combination product regulation . . .
--2401,3,400,2291,12004