Regulatory eSubmissions, LLC will facilitate your company’s selection process when determining the choice of software or services for eCTD production.
When making the choice to produce your own eCTDs a number of factors must be considered. The production of eCTDs requires specialize software, dedicated and trained professionals who will use the software to produce your eCTDs and hardware/software associated with the software selected. Will your organization have a sufficient volume of eCTD activity to warrant the ongong cost of software maintenance, personnel resources and maintain personnel skill levels?
When making the choice to partner with a service provider who will produce your eCTDs a number of factors must be considered. How will information be exchanged with the service provider, what are their expectation regarding the delivered submission components, will they be flexible when timing changes, how much will that flexibility cost?
Regulatory information is your organization's most valuable possession and its effective and efficient delivery to regulatory agencies is paramount to your success. Regulatory eSubmissions, LLC has the experience to ask the correct questions to assess your organizations best path forward for eCTD production.