WEST CHESTER, PA--(Marketwire - June 12, 2009) - EXTEDO, a key eSubmission
solutions provider for life sciences firms, today announced that Tosk,
Inc., a biopharmaceutical company dedicated to improving the safety of
drugs marketed for debilitating and life-threatening diseases, is using the
eCTDmanager Suite™ to reduce the time
and cost of drug regulatory filings.
The EXTEDO eCTDmanager Suite provides Tosk, Incorporated with an
easy-to-use electronic management solution for building, viewing,
validating, and publishing compliant submissions that meet global
"The EXTEDO solution has helped the development group at Tosk save both
time and money when it comes to preparing and submitting drug regulatory
filings. In the past it would take us about two weeks just to print and
assemble the documentation to manually file an Investigational New Drug
(IND). The printing cost alone for the application would typically cost
$5,000," stated William Garland, VP of Research and Development at Tosk.
"With minimal training we had a small staff with no previous submission
experience up and running on the EXTEDO solution in a few days. The EXTEDO
solution allowed us to complete the assembly and filing of an IND in less
than 60 days. That is at least 30 days less than the old manual way. We
feel that we are going to be able to cost justify the EXTEDO solution after
just two IND filings."
"The FDA reviewers want to receive IND applications electronically," said
Martens, Vice President for North America and Japan at EXTEDO. "The
eCTD format provides a significant benefit to both sponsor and reviewer
during the IND phase. It makes IND lifecycle management much easier and
provides the reviewer with an easy to navigate electronic index of the
Tosk, Inc. is a biopharmaceutical company located in Santa Cruz, CA that
discovers and develops adjuvants to use with generic drugs used to treat
cancer and other diseases. Tosk has innovated and patented a drug
discovery platform based on drug screening in fruit flies that it uses to
develop new pharmaceutical products that reduce the undesirable side
effects of existing drugs while maintaining their efficacy. Tosk calls
this platform Optimizing Marketed Drugs™ ("OMD™"). The OMD
technology enables Tosk to efficiently identify side-effect-reducing
compounds that would be difficult and costly to discover using traditional
More information can be found at the Tosk website, http://www.tosk.com.
For nearly 15 years EXTEDO has been a key services and solutions provider
in the field of regulatory data and document management (CTD, eCTD and
other formats) for Life Sciences industries and authorities
(Pharmaceutical, Crop Science, Chemicals). Based on well-founded expertise
and many years of experience, EXTEDO provides highly standardized as well
as customized solutions in the area of electronic Regulatory Affairs.
EXTEDO, being globally represented, serves more than 600 Life Sciences
organizations in more than 50 countries.
For more information visit www.extedo.com.