SciRegs International Inc. will provide you with access to a dedicated Electronic Document Management System (EDMS). The EDMS solution provides content versioning, check-in and check-out capabilities, audit and security while providing an online accessible collaboration platform.
Electronic FDA Submissions
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. SciRegs International, Inc. is able to provide all services for DMF, NDA and ANDA FDA submissions adhering to the eCDTD standard. This includes document production and submission through the FDA secure gateway. Should the FDA gateway suffer from an outage, our office location provides the ability to drive the submission over on other electronic media.
Structured Product Labeling
The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. SciRegs International, Inc. provides the ability to adhere to SPL standards without the need to purchase additional software and training.