Product Overview
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.
- 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
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
- 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.
About the company
Established in 2005, AXSource is a Tech backed consulting company providing services to 2 main verticals of a business, Regulatory & Quality and Digital Transformation. Our team of experts has a wealth of experience in these areas and is dedicated to helping our clients achieve their goals.
