The fastest way to submit Drug Master Files to the U.S. Food and Drug Administration (FDA) is by Electronic Common Technical Documents (“eCTD”) submission. Since eCTD formatted applications are submitted electronically, FDA receives the submission instantaneously. The eCTD format also decreases the time needed to review DMF applications. All of these translate into more ease and less time pressure for companies submitting DMFs to FDA.
Although there are many advantages to using the eCTD format, the eCTD format ordinarily is not feasible for companies that do not submit large volumes of DMF files. A company that does not submit many DMFs may find that the investment in the base technology and skills is too expensive, complicated and time-consuming to justify its use in only a few DMF submissions.
Now, however, the eCTD format is available to DMF submitters without the need for large investments of resources. Registrar Corp’s Regulatory Specialists are experienced in eCTD submissions. Registrar Corp assists companies with electronic DMF submissions by converting documents for DMF applications into the eCTD format and submitting them to FDA on behalf of a company. Registrar Corp can also function as the agent for all FDA communications regarding these submissions.
Contact Registrar Corp now to save time and money on your DMF application. If you are interested in using Registrar Corp’s Electronic Common Technical Documents (eCTD) submissions service or have any questions about FDA regulations, please contact Registrar Corp at +1-757-224-0177 or 24/7 at www.registrarcorp.com/livehelp