A cost-effective, easy-to-deploy approach for handling regulatory filings
Extedo and MasterControl have launched a new integrated solution at the DIA Electronic Submission Conference in San Diego. The integration between Extedo eCTDmanager suite and MasterControl documents provides customers with an end-to-end solution for the management of documents and submissions to global life sciences regulatory agencies.
Submissions can be delivered in any format required by a regulator, electronic common technical documents (eCTD), Non-eCTD electronic submissions and paper submissions.
Harv Martens, vice president for North America and Japan at Extedo, said: By ensuring the management of both document and submission lifecycles in a single solution life sciences firms will be able to bring new products to market faster by accelerating in-house approvals, and ensuring that submissions are complete and accurate before they are sent to the regulator.
Bryan Koslow, global vice president at MasterControl, said: We have seen a sizable increase in demand for an end-to-end document management and electronic submissions suite. This integration between MasterControl and Extedo represents the next generation in eSubmission solutions and provides our clients with a cost-effective, easy-to-deploy approach for handling regulatory filings.