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Electronic Drug Listing and Drug Registration
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Intagras' Saas Approach
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Legislation
Recent congressional legislation (H.R. 3580, Section 224) requires drug
registration and listing to be submitted in electronic format to the Food and
Drug Administration (FDA). In an effort to comply with this legislation, the
FDA is currently considering using SPL as a means to obtain this information.
Implementation
It is expected that the FDA will implement and require compliance with electronic
listing and registration early in 2008. This will mean companies will need to
find existing software, services, and expertise in this area. Intagras has some
of the industries leading SPL subject mater experts, and has been providing SPL
services since the implementation of SPL for product labeling in October of 2005.
Providing Software as a Service your organization
Intagras provides our clients with an online subscription based application that
allows for the creation and management of electronic based FDA Drug Listing and
Registration. This approach provides our clients with a secure means to remain
compliant with the FDA electronic guidance (SPL), by leveraging our subject
matter expertise.
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