SPL Conversion
Apyx has provided SPL conversion services since 2005 and has also developed its own Word-based tool for creating SPL labels. Our full SPL conversion services convert your existing Microsoft Word-based Package Insert into FDA required Structured Product Labeling (SPL) format using our SPL Manager® conversion application. In addition to converting your text-based product label to SPL, with our SPL R4 release, we support Establishment Registration and NDC Labeler Request submissions as well.
All Apyx conversions are validated using FDA's Validator prior to completion.
Apyx executives have been active members of the SPL Working Group since 2005 and have spoken at multiple DIA conferences about SPL.
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.