SAGE SUBMISSIONS, LLC
The world of electronic regulatory submissions is a quickly evolving and ever changing field.
Submission of compliant applications in a timely manner is a key to the successful development of drugs,
biologics, and devices. Traversing the myriad of old and new regulations, guidances, and variations
across regions can be quite complex, particularly in light of recent initiatives, such as eCTD, SPL, PLR,
PIM, ESG, etc…
The aim of Sage Submissions, LLC is to provide consulting services, products, and expertise, to help
companies transition into the electronic submission environment, or improve upon existing processes
to reduce preparation time and increase compliance.
Mandatory electronic submissions are on the horizon. Current estimates are within 3-5 years(1).
Will you be ready?
OVERVIEW
1 (18 December 2006 : FDA Public Hearing – “ Electronic Submission of Regulatory Information, and Creating an Electronic Platform
for Enhanced Information Management).”
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