Monday, March 2, 2009

Clinical FSP

Beginning June 1, 2009 electronic submission will become mandatory!

The eCTD has been rapidly moving towards the preferred, and now, mandated electronic submission format. The FDA requires all submissions to be made electronically only beginning June 1, 2009. And this time, the makers of biologics, vaccines and OTC products are also included!

For those organizations that have not yet developed the requirements and processes for this new submission standard, the window to prepare for it is closing.

At MaxisIT, we have developed simple, yet powerful, web-based software that can expedite your ability to produce and validate the XML documents automatically utilizing your existing documents management system while ensuring end-to-end consistency and traceability.

Our software eSUBMIT offers you the functionalities to produce, review and submit the eCTD and SPL 4.0 compliant document in a web-based parameter driven, collaborative work environment supporting geographically distributed user base.

Why spend precious man-hours developing your in-house solution or working with products that involve lot of manual interventions when you can have MaxisIT complete in days what such solutions might take months to organize? We can save you the frustration and the chance of missing key submittal requirements that can cost you hundreds and thousands of dollars.
MaxisIT is a CDISC associate member and an active implementer since 2003. Call 1-877-MAXISIT (629-4748) / 732-494-2005 ext.104 today to find out how we can save you money and time. Our specialists are available to demonstrate our product that produces the eCTD and SPL 4.0 compliant documents using a web-based solution and also answer any questions that you may have.

Maximize your returns with MaxisIT.

No comments:

Post a Comment