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SAGE SUBMISSIONS, LLC
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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...
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The aim of Sage Submissions, LLC is to provide consulting services, products, and expertise to help pharmaceutical and biotechnology companies transition into the electronic submission environment or improve upon existing processes to reduce document and submission preparation and development time, and increase compliance.
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Mandatory electronic submissions are on the horizon. Current estimates are within 3-5 years.
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Will you be ready?
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