Bringing New Products To Market Faster

The U.S. FDA has expressed their intent to require electronic submissions to be delivered in eCTD format by January 1, 2008. Getting ready for the development, assembly, and publishing of eCTD submission can result in long learning curves and delayed market applications.

Let the experienced consultants at TSRI Life Sciences help ensure your market readiness for electronic submissions.  Our team offers practical, hands on experience and best practices to get you up and running quickly.  We are familiar with the latest technology and industry guidance to accelerate your adoption of the eCTD. 

OUR CONSULTANTS

Our strategic consulting services include:

• eCTD Publishers

• Regulatory Content Management Specialists

• Scan/Input Capture Specialists

• Medical Writing

• Regulatory Operations Specialists

• Project Managers

• Medical Affairs Specialists

• ... And More!

Electronic submission publishing and assembly is often time-consuming and takes critical resources away from your core business.  Let the experts at TSRI help you accelerate your adoption of the eCTD format.