eCTD Publishing & Submission Services – AXSource
Regulatory filings in electronic CTD have become the mandatory or preferred method for many regulatory agencies. AXSource Consulting offers regulatory submission compilation and filing in the electronic Comment Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS) formats. Our regulatory experts will prepare, publish, validate and review your submissions for more cost-effective filings. With the added benefit of having our on-site IT company and our own ASA (AXSource Secure Architecture), AXSource is more than ready to support all your eCTD outsourcing needs.
There are enormous benefits to outsourcing your eCTD Services:
AXSource Secure Architecture (ASA)
Reduce the impact on internal resources
Eliminate cost for an expensive in-house system
Expedite regulatory review by using our experienced publishers
Validation of your eCTD submission(s)
Reduce administrative & maintenance burden
Electronic Submission Types
|Electronic CTD(eCTD) Services||
|NeeS||Supporting clients with preparation & review of Non-eCTD electronic submissions.|
|Device, NHP & Cosmetic e-Filings||Medical Device submission (FDA eSubmitter), NNHPD submissions (Trading Partner) and Cosmetics registrations are supported.|
SPM & SPL Labeling
AXSource offers professional services in Structured Product Labeling (SPL) for Health Canada and the United States FDA.
Electronic CTD(eCTD) Outsourcing for Consulting
If you are a Regulatory Affairs contractor or independent consultant, please contact AXSource to fully support your Electronic publishing needs. Request a meeting today by contacting Sales at firstname.lastname@example.org.