PTS Consulting Global Services provides compilation, authoring, publishing and submission services for various application types. Our submission services include associated submissions in addition to the original applications (amendments, supplements, annual reports).
Electronic Submissions (eCTDs)
eCTD ESG ANDA filings, 505b2 filings, IND filings, and DMF fillings. Submission of ANDAs, NDAs, INDs, and DMFs.
Paper Applications/CTD/Traditional Format
The FDA is going to require electronic filings for all submissions. We can convert paper applications to eCTD and file on the ESG (Electronic Submission Gateway)
PTS Global Services works with our clients to determine the level of need and provide support that the client requires including necessary templates for authoring of electronic documents and regular update reports once the compilation, authoring and editing process begins.
PTS Consulting Global Services provides turnkey comprehensive electronic submission services that are cost and time effective for therapeutic and diagnostic biotechnology products. We provide a wide range of services including eSubmissions.
Through our partnerships, we operate a secure ESG which allows direct delivery of submissions to FDA like an e-mail. No mailing, no delivery delays, critical for first to file and PIV opportunities. Compliant submissions reach division within 15 minutes of transmission.
Secure email communication with regulatory agencies results in quicker and higher response rate and can often substitute paper mails, including electronic digital signatures and certifications.
We have the capability to provide electronic NDC Labeler Code Request, Facility and Drug Registration, and DUNS number mandated by regulations in July 2009. We implemented use of FDA’s eSubmitter that allows preparation and submission of eclectic standardized electronic submissions across various FDA Divisions.
PTS Global Services include:
We also possess the capability to convert your prior paper submissions to electronic format, and hence, giving you the ability to submit future submissions electronically which saves resources, and moreover, is reviewer friendly