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 Agency Interaction Representation

When it comes time to speak with a regulatory agency related to your eCTD plans, Regulatory eSubmissions, LLC can be present as your eCTD expert partner.  We have directly interacted with various regulatory agencies (US, Canada, various EU countries, Japan, Australia) in support of New Drug Applications (NDA) and Biologic Licensing Applications (BLA).  We have existing relationships with key regulatory agency electronic submission contacts and can reach out to these individuals to address any specifics associated with your organization’s regulatory filing.  We have been present during preNDA, preBLA and other agency interaction meetings for submissions to various therapeutic areas.

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