eCTD Publishing & Submission Services
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.
XML PM & SPL Labeling
AXSource offers professional services in Structured Product Labeling (SPL) for Health Canada and the United States FDA.
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 |
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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. |
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| 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. |
