Tosk, Inc. Reduces Submission Time and Cost for Drug Regulatory Filings With EXTEDO eCTDmanager Suite
Published: Jun 12, 2009
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 regulatory specifications.
"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 Harv 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 cumulative information."
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 methods.
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.
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