Enabling Digital Transformation of the Regulatory Value Chain
The Orion team strongly believes that regulatory information must be treated as a corporate asset – in other words, it’s important to collect, curate and manage regulatory information in a highly regulated manner. And it’s equally important to embed both data quality and data governance into the collection and management processes so that appropriate controls are outlined and allocated for ahead of time.
Regulatory information takes various forms across the value chain based on the needs of each functional area within regulatory. The regulatory intelligence function requires access to updated regulations, guidance and interpretations of regulatory activities in order to adequately support regulatory affairs needs, define regulatory strategies for products in certain markets and understand the specifications for submissions. Therefore, submission plans must be created with the following purposes in mind: creation, review and approval.
In transitioning from one stage to the next, documents become part of submissions which then become part of registrations. During the registration process, one must track and manage interactions, queries, responses and commitments with health authorities until the product is approved and lifecycle management activities can continue. The entire process relies heavily on the creation, curation and management of data, meta-data, documents and submissions.
The Pharma & Life Sciences industry has come to the realization that management of such vast amounts of data and documents requires major transformation of current processes and technology capabilities.
Transforming Regulatory Information Management
The key to managing regulatory information as a corporate asset is to transform the Regulatory Information Management (RIM) landscape with end-to-end capabilities or solutions that are fully integrated, allowing for seamless transfer of data and reducing data quality issues due to manual handoffs or duplicate data entry into siloed applications.
The Orion team has expertise in various activities related to end-to-end implementation, such as:
- Defining the enterprise architecture vision and road map using information architecture techniques
- Understanding and gathering business and functional requirements through business analysis workshops and user interviews
- Conducting technology and vendor assessment to meet end user business and functional needs by utilizing score-card based evaluation and return on investment approaches
- Designing/redesigning business processes to support the collection, curation and maintenance of high-quality regulatory information
- Integration of chosen RIM capabilities with other enterprise applications
- Supporting the global deployment of RIM capabilities
- Managing organizational change before, during and post deployment to encourage user adoption of transformed processes and technology solutions
- Identifying processes for data collection, data governance and data quality monitoring
Harnessing Regulatory Intelligence
Most life sciences organizations face challenges in the collection, curation and management of regulatory intelligence. There are endless sources, such as Excel spreadsheets, homegrown databases and expensive subscriptions to commercial sources, that don’t allow for actionable intelligence or properly integrate with the regulatory value chain, often resulting in downstream delays, inefficiencies and potential loss of revenues.
We support the digital transformation of regulatory intelligence function by:
- Evaluating the regulatory intelligence landscape, processes and capabilities
- Recommending process changes and technology solutions to harness hard and soft intelligence
- Configuring and deploying our proprietary ReALM® GRIP platform on Microsoft Azure to manage regulatory intelligence in actionable ways
- Integrating regulatory intelligence and checklists to drive submission planning, dossier creation and publishing processes
End-to-end regulatory information is beneficial not only to streamline internal processes within regulatory but also across other functional areas that are dependent on regulatory information, such as clinical, labeling, safety and manufacturing.
We have successfully integrated RIM with enterprise product portfolio planning and management systems, clinical trial management systems, quality management systems and master data management systems.
The Orion team has created frameworks, methodologies and accelerators to integrate on-premise cloud applications with enterprise applications using AWS and other capabilities. Learn more about our Cloud & Infrastructure Services.
Over the past few years, most life sciences companies have gravitated towards new processes and technologies to streamline regulatory information management. It’s time to realize the fruits of these investments by improving decision making and using the robust data that’s available in end-to-end capabilities.
At Orion, we enable the discovery of actionable insights by helping clients ask the right questions when it comes to RIM data, creating KPIs and dashboards, and transforming ways of working within regulatory, all in order to be more proactive.