Miscommunication ranks as the number one reason for delay in the review process of electronic submissions according to the U.S. Food & Drug Administration. Fortunately, these costly interruptions are preventable.
Receipt of a Complete Response Letter, or worse yet, a Refuse-to-File notification, is likely the result of asymmetry of information between the regulatory agency and the sponsor. Ensuring eCTD submission success begins and ends with closing this information gap.
What is the best way to accomplish this?
Sponsors can virtually eliminate the risk of technical rejection by using the FDA’s error detecting system prior to submitting. GlobalSubmit REVIEW™, which is used exclusively by reviewers at the FDA, facilitates the electronic submission process by providing both sponsor and regulator with an identical vantage point. With this shared perspective, you will have confidence that your submission is correctly formatted and that no technical errors remain in the submission, thus eliminating the risk of technical rejection.
Furthermore, the REVIEW platform includes insight and innovation other systems cannot offer. For example, users of REVIEW can now take advantage of the Link 2 Share feature. It allows each party involved with an electronic submission to locate crucial information through the simple copy-paste action of a hyperlink. Internally, REVIEW encourages collaboration through the creation of favorites within a submission.
In the world of electronic submissions, transparency translates into confidence. REVIEW overcomes asymmetry of information between sponsor and Agency, and gives your submission a the highest probability of approval.
Key Features of REVIEW:
- Shared Screen – Share your screen with reviewers at the FDA
- Multiple Views – View your application’s Full Lifecycle, Origins, Regulatory Activities, etc.
- Clear Communication – Identical vantage point with the FDA improves sponsor-agency communication
- Multiple Formats – Complies with eCTD, NeeS and RPS
- U.S. FDA – 2.01, 3.3
- EU – 1.4.1, 2.0 and NeeS
- Health Canada – 2.2
- Australia (TGA)
- Swissmedic – 1.1
In a multi-tenant or public cloud environment, many users are accessing a single instance of a software program running on a server. Here, GlobalSubmit’s Submissions Management Suite is running on shared Amazon Web Services (AWS) infrastructure. Submission data for each company is partitioned into unique, secure buckets within the shared AWS server. These buckets are only accessible with the proper login credentials.
Terms to describe cloud computing for life sciences regulatory publishing are causing some confusion. For the purposes of clarification, GlobalSubmit is technically the SaaS software provider while AWS is the provider of the cloud infrastructure hosting the SaaS application.
Clients who elect to purchase a private Secure CLOUD deployment do not share AWS infrastructure with other users. One of the primary benefits of a private deployment is flexibility with regards to timing of software upgrades.
A local installation of GlobalSubmit’s Submissions Management Suite allows for complete control over system upgrades, security and validation. Such an installation would require more internal IT resources. Upfront costs and installation time associated with a local installation is greater. Performance, however, is regulated and monitored internally, giving users greater autonomy over the system.