Regulatory Submissions


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™

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


Connected and Secure Management


Version and Revision Control


Streamlined Processes

Trusted By


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.


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.

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