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Managing regulatory information is far more complex when supporting multiple markets. An everyday event such as a manufacturing change or regulatory authority request triggers waves of necessary activities as you assess the impact, submit updates, and ensure affected regions remain in compliance. Each step is made harder by the fragmented nature of regulatory systems today.
Let’s look at a typical process.
You begin the assessment by checking headquarters’ registration tracking system, requesting information from affiliates, and following up with calls.
Next, aggregate the information in your project tracker and add placeholders in your submission schedule.
Now, manage authoring and reviews in one system and publishing in another.
Dispatch the submission to impacted regions and locally track agency responses.
Finally, store the dossier with thousands of others in a basic file share.
With planning execution and tracking in separate systems, compliance is challenging and visibility is nearly impossible. Technology limitations were largely to blame. This has now changed with Veeva RegulatoryOne’s unique ability to manage content and data.
RegulatoryOne eliminates information silos and streamlines regulatory processes. That change event is now assessed within a global registration management system that links regulatory data to the original source documents and dispatch submissions. Real-time tracking shows the status of submission documents and regulatory activities across all affected markets.
There’s one system for one view across regulatory and around the world. To see how Veeva RegulatoryOne can help you move faster, gain visibility, and strengthen compliance, visit our website.