PMTA Submission Service – Mail

Service Description:

– PMTA Submission Service
– Submission by Mail
o Applicable for applicants who cannot submit the PMTA online.
o Note that the proposed rule for PMTA, when finalized, would require an applicant to
submit a PMTA and all supporting and related documents electronically in format that
the FDA can process, review, and archive.
o Includes printing services for PMTA bundling preparation.
o Includes postage for PMTA submission.
– Submission service does not include PMTA Application Preparation
– This is a submission service for the PMTA. Content(s) and
document(s) to be printed and 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
– Quantity: 1
– PMTA submission via Mail

Delivery Date:

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