10 Small Submissions
No more than 10 Documents per submission
eCTD submissions are now being prepared by Freyr SUBMIT PRO that helps faster streamlining of the process through eCTD version 3.2.2 and version 4.0. It provides an end-to-end software solution to meet the eCTD publishing and submission commitments within stipulated timelines, which is now capable to serve with the eCTD v4.0, which is based in Health Level Seven (HL7) standard called RPS. The reliability on this update provides a Regulatory compliance support that has eased the eCTD publishing through Freyr SUBMIT PRO that has enabled better publishing capabilities which in turn will give quicker approvals, better market access meeting eCTD submission requirements.
GUARANTEE YOUR ROI WITH AN eCTD SOFTWARE THAT OPTIMIZES COST-PER-SUBMISSION
Cutting-edge technology - eCTD publishing and submissions based on machine learning
Compliant – Supports 21 CFR Part 11 standards for compliant eCTD submissions for various health authorities
Efficient - Efficient eCTD submissions backed up with features like cloning, cross-reference, capability to integrate with leading rDMS and PDF manager
Flexible – Cloud-based | On-premise deployment that suits your eCTD submission requirements
Freyr SUMBIT PRO is an eCTD publishing software that enables you to compile, review, validate, and publish your submissions across the globe in an accelerated fashion.
Freyr SUBMIT PRO shall have support for FDA eCTD 4.0