Rx

Regulatory

Submissions Management Software

MasterControl’s submissions management software helps ensure product submissions are connected, secure and efficient.

Increasing digitization and more stringent FDA requirements mean life sciences companies must adopt a more disciplined approach to product submissions. Companies that don’t begin to create and publish submissions-ready documents in early stages of the clinical process will face delays and reduced speed to market. The solution is an automated submissions management tool that supports the full life cycle of the submissions process.

MasterControl Reference Model - eCTD JumpStart™
Download

Don’t let paper-based systems cause costly delays and lost revenue during your submissions process.

01

Connected and Secure Management

rx-submissions-management-connected-secure-management-555x312

A submissions management solution allows your publishing tools secure access to MasterControl’s electronic trial master file (eTMF). It also provides your submissions materials with front-end document management prior to regulatory submissions.

02

Version and Revision Control

rx-submissions-management-version-revision-control-555x312

A digital submissions tool guarantees users are working on the most current versions of documents. Approved versions of updated documents are automatically exported securely to the cloud and assigned affiliated submission serial numbers.

03

Streamlined Processes

rx-submissions-management-streamlined-processes-555x312

Submissions software manages all your document needs for submission to save you the time of preparing them manually or using disparate systems. The tool provides front-end organization by storing all your docs in MasterControl’s eTMF for faster and more efficient submission.

Trusted By

rx-submissions-management-regulatory-submissions-software-525x525

Learn more about how electronic regulatory submissions software can save your company time and resources.

Electronic submissions software automates your FDA submissions to ensure regulatory compliance with 21 CFR Part 11. The MasterControl solution helps pharmaceutical companies effectively and efficiently manage every stage of the change control process.

rx-submissions-management-automated-approach-md-submissions-525x525

Find out how an automated approach to medical device submissions can more efficiently help your device get 510(k) clearance or premarket approval.

Securing FDA 510(k) clearance or premarket approval can be a demanding process. Make it easy by using an electronic registration solution that automates manual and hybrid processes for requirements in each market.

Organize your submissions documents and ensure they’re compliant from the get-go.

Submissions management doesn’t have to be drudgery. An automated submissions management solution can help you streamline the submissions process.

Download the Data Sheet