Electronic Submission Expertise
Regulatory eSubmissions, LLC
eCTD Service or Software Selection
eCTD Vendor Selection
eCTD Agency Interaction Representation
eCTD Production Efficiency Evaluation
eCTD Readiness Assessment
eCTD Specialized Areas Expertise Partners

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.  

HomeServicesWhy Regulatory eSubmissionsOur HistoryNews and EventsContact UsLegalSite Map