Obtaining regulatory approval and maintaining regulatory compliance is a complex task that involves dozens of stakeholder groups working in a coordinated manner over a period of years. This is often achieved through the heroic efforts of regulatory affairs employees who go above and beyond to ensure that the product they support gets to market. Thankfully, due to the improvements in technology it may no longer be necessary for us to hire only supermen and superwomen and pray for success.
Over the years, many companies have implemented regulated content management systems to support clinical, regulatory, and quality operations and manage content that must be submitted to regulatory authorities. This has helped to control the documentation that is required, but similar to only having the ingredients required for baking a meal and not the step-by-step recipe, it has not produced the results we were all hoping to see.
Why? Regulatory operations/affairs involves so much more than ensuring content is present. It requires that we gather information from many stakeholders (internal and external), digest this content and create actionable plans, and then follow-through on this plan and any resulting activities. Traditionally this information/plan has been documented in disconnected systems or on paper files within the regulatory affairs office. This has led to missed milestones, regulatory findings, and delays – all outcomes which delay approval and cost Life Sciences companies money.
Addressing the full spectrum of Regulatory Information Management, Paragon’s RIM framework enables life sciences organizations to automate and streamline processes and establish best practices in each of the following areas:
Registration Management Efficiently track which submissions have been approved, in what countries, etc.
Regulatory Intelligence Keep your finger on the pulse of new regulations, what they mean, and what others are doing to address them.
Labeling Management Manage XML labelling content creation and revisions across versions and countries.
Pharmacovigilance Management Proactively manage adverse events and report to appropriate stakeholders.
Submission Planning and Management Integrate submission plans with product development plans to reduce time-to-market and improve collaboration and process integration of document authoring, review, and approval.
Correspondence Management Effectively manage regulatory correspondence and notifications.
Commitment Management Receive notifications to keep track of regulatory commitments and ensure they are met.
Promotional Materials Management Effectively manage the entire lifecycle of promotional materials from creation through dissemination and retirement.
Chemistry Manufacturing & Control (CMC) Management Understand the impact manufacturing changes have on regulatory filings and ensure appropriate approval by health authorities before implementation.
Improving Regulatory Operations
Over the past few years, we have witnessed the deployment of regulatory information management systems which allow us to aggregate this information, reduce confusion, and ultimately improve our execution of regulatory operations.
The maturation of this field of systems is exciting to us, but we must be mindful that no tool can ensure compliance or make people operate more efficiently. We need to augment these software packages with carefully thought out implementations that ensure that company-specific systems, operating models, and processes are supported.
Paragon has helped its clients implement Regulatory Information Management systems that enable teams to more efficiently manage all facets of regulatory affairs. To learn more about Paragon's Regulatory Information Management Framework download Paragon's data sheet.