Highest
Quality Conversion In The Industry
- Still uncertain how to handle your
submission process?
- Need more capacity or capabilities than
your current processes or vendors provide?
There is a solution. By choosing ThinSpring,
you will get help from a conversion
services provider with solid experience, already having
converted hundreds of SPL labels, having many more contracted
for the coming year and having three of the world’s
five largest pharmaceutical manufacturers as part of
their growing client list. You will solve your conversion
challenges immediately. And, if you choose, you will
be ahead of the curve when it comes time to bring conversion,
validation and submission in-house with ThinSpring’s
SPL Server™.
Ready for the SPL Physician Labeling Rule (PLR) Challenge
Bound by federal mandate, the United
States Food and Drug Administration (FDA) has required
that all NDAs,
BLAs, and Efficacy Supplements submitted after June 30,
2006 conform to the SPL-PLR rule. In addition, all NDAs,
BLAs, and Efficacy Supplements approved since June 30,
2001 must be converted to the SPL-PLR format in the course
of a 7-year implementation window.
The addition of the Physician Labeling Rule (PLR) requirements
to the SPL submission represents the first major change in the
insert labeling in 25 years. All of the ThinSpring Team software
and services are designed for complete compliance with the new
SPL-PLR requirements. In addition, we’ve partnered with specialists
Quadrant eLabeling (QeL) to create the technically sophisticated
Highlight Text section with Custom SOW Definition, FPI creation
and verification, highlight codes, and FDA support through the
examination and approval process. To find out more, read our SPL-PLR
Conversion Services data sheet.
ThinSpring was formed to provide
you with a powerful set of solutions for your regulatory
compliance success. Quality outsourced conversion services
today and a clear migration path to a powerful internally
implemented software solution tomorrow. |
