eCTD Consulting & Services

eCTD Publishing & Submission Services – AXSource

AXSource 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.

Regulatory filings in electronic CTD have become the mandatory or preferred method for many regulatory agencies. According to Health Canada, as of September 2017, 87% of regulatory activities for drugs were filed in electronic CTD format. Additional file types will be added in the near future. Health Canada will also be accepting Division 1 and Division 8 (human drugs) regulatory activities in both eCTD and non-eCTD formats as part of pilot first in 2019.

There are enormous benefits to outsourcing your eCTD Services:

ECTD Services - ectd publishing & Submissions

 

 

 

AXSource Secure Architecture (ASA)

System Hardware & Software We understand the importance of keeping your intellectual property safe. AXSource offers secure publishing and maintenance of your electronic regulatory submissions. We employ one of the top publishing software’s available and utilize our own hardware for data storage. Company-wide data security protocols have been implemented.
Data Maintenance

AXSource Secure Portal (AP)

We have two main competencies: Regulatory Affairs & Information Technology. Our ASA is completely owned and controlled by AXSource. Data is securely maintained, regularly backed up and supported by a Disaster Recovery Plan.

If a secure Cloud Service is desired, this can be managed as well for convenient and secure exchange of client data and documentation.

 

 

Electronic Submission Types

Electronic CTD(eCTD) Services
  • We fully support the preparation, conversion, and compilation of your documentation for conformance to regulatory agency requirements (i.e. FDA, Health Canada, TGA, etc.).
  • Gateway Submissions: FDA Electronic Submission Gateway (ESG), Health Canada’s Common Electronic Submission Gateway (CESG), etc.
  • Query Management to support clients.
  • Complete validation and acknowledgement.
  • Where necessary, supplementary support for paper, documentation, compact disk and/or USB devices is accommodated.
  • Health Canada electronic CTD: NDS, SNDS, ANDS and SANDS; Non-electronic CTD electronic-only: Medical Device and Veterinary Drug regulatory activities.
  • FDA eCTD: NDA, BLA, ANDA, CTA, DMF and IND.
  • European EMA eCTD: Original, Variations, MAA-CP, DCP, MRP, CTA, DMF etc.
  • TGA (Australia Government): Registration Applications, Master files, PSURs etc.
 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.

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 info@axsource.ca.