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