PMTA Submission Service – Online

Service Description:

– PMTA Submission Service – Online
– Submission Online
o Submission preparation electronically using FDA’s eSubmitter software and eSubmitter
template “CTP Transmittal Form or
o Submission online via the CTP Portal
o Includes, if applicable, request for an Industry Account Manager (IAM) account to
establish CTP portal account service.
– Submission service does not include submission by Mail.
– Submission service does not include PMTA Application Preparation
– This is a submission service for the PMTA. Content(s) and
document(s) to be submitted to FDA are your firm’s
responsibilities and must be provided for the completion of the
PMTA’s submission service.
– PMTA acceptance is based on meeting the FDA regulatory
requirements.

Requirements:

– Provide all applicable content(s) via email to
services@consultareinc.com.
– Send all applicable documents for submission to
services@consultareinc.com.
– Google Meet – Screen Share for discussion. To be scheduled by our
Compliance Team.

Deliverables:

– PMTA Submission Service – Online
– Quantity: 1
– PMTA submission via applicable FDA online portal(s).

Delivery Date:

– 10 to 15 Business Days upon receipt of completed information or
documents required for inputs.