Regulatory Submissions

Overview

A pharmaceutical company must file documents to the appropriate health regulator for new product registrations, clinical trials, label changes, and more. These submissions are typically a set of documents created by various teams within the regulatory group of the pharmaceutical group.

The regulatory submission process is often faced with a range of challenges that can impact the pace of submissions and their outcome. See how Princeton Blue’s Regulatory Submission helps orchestrate the entire workflow from document identification to approvals to submission.

Following are the challenges with Regulatory Submissions:

• Reliance on individual expertise: Since each country has its own regulatory requirements driven by several factors such as product, and type of submission, amongst others, there is heavy reliance on an individual’s experience and expertise to drive this process.
• Limitations of rudimentary tools: Often, the regulatory submission process is executed and tracked using rudimentary tools like Excel, SharePoint, and email, limiting the flexibility in operations and leading to lack of efficiency.
• Missing data integration: Lastly, regulatory submissions are often managed by old legacy systems that don’t talk to each other. Manual data management and an outdated user experience causes fatigue and creates data inconsistencies.
• No process transparency: Since a submission request can span multiple countries, rudimentary tools do not provide the visibility into the latest submission status, thereby limiting the regulatory team’s ability to take effective decisions, potentially delaying the regulatory submission.

Key Features & Functionality

Princeton Blue’s Regulatory Submission solution automates the processing of creating, approving and submitting various types of regulatory documents using the Appian Low-code Process Automation technology. -

• The solution orchestrates the entire workflow from document identification to approvals to submissions.
• It integrates and extends your existing applications that support regulatory operations to bring data and documents into the context of the process.
• It provides an agile and modern user experience across different devices and form factors.
• Provides insight into the regulatory submission operations via interactive graphical dashboards and reports.
• The solution is also easily customized and adapts to your needs.