Apotex, Inc. has selected Sparta Systems, Inc.'s TrackWise as its global solution to capture and track all regulatory information required for new products and product lifecycle management. TrackWise is a web-based software platform that allows organizations to implement a secure and expandable tracking solution to manage regulatory compliance data, activities and work processes.
Apotex produces more than 300 generic pharmaceuticals in over 4,000 dosages. The TrackWise system will provide Apotex with an electronic, integrated solution to manage Product Life Cycle Management (PLCM) activities required to meet expanding global market needs. The system will be used to manage submissions, amendments, change notices, periodic safety reports, commitments and other regulatory activities.
"The vision of this system is to create an efficient, cost effective, global solution to track all required regulatory information pertaining to new products and product lifecycle management," stated Michael Davidson, chief information officer for Apotex. "Apotex selected TrackWise because it meets our functional requirements, and it provides our organization with a scalable and configurable web-based architecture, which has the ability to adapt and grow as our company's needs evolve."
"Sparta is pleased to be awarded this contract, and looks forward to a long lasting partnership with Apotex" stated Steve Cagle, vice president of marketing and product development at Sparta Systems, Inc. "Improving regulatory affairs tracking systems enables companies to be more efficient and effective in their product approval process. We expect TrackWise to help Apotex improve its time to market and decrease costs associated with meeting ever-increasing regulatory compliance requirements."