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eCTD Specialized Areas Expertise Partners | |
Leveraging key partnerships we provide eCTD publishing services.
Additionally, there are aspects of the eCTD which can require targeted subject matter expertise. A few areas where specialized knowledge can be indicated include: dataset formatting (SDTM, ADaM, SEND), CMC (granularity, nomenclature), labeling (SPL, PIM, PLR), scanning, etc. Regulatory eSubmissions, LLC has relationships with providers in these distinct eCTD knowledge areas and can bring these parties on board when appropriate.
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