In the ever-evolving landscape of pharmaceuticals and life sciences, the journey from innovation to market intricately goes through the regulatory affairs. At the core of this, lies Dossier Submission – a vital step demanding precision, adherence, and a sharp focus on compliance. In this exploration, we’ll dissect the intricacies of the traditional workflow, spotlighting its challenges, and then unveil a groundbreaking solution that has the potential to completely resolve challenges and act as the regulatory landscape.
Understanding the Significance of Dossier Submission-A Regulatory Ballet:
A collection and variety of documents pertaining to the quality, safety, and efficacy of a medicinal product are referred to as a dossier in regulatory affairs. A regulatory body receives the dossier for review, and if the submission is accepted, marketing authorization for the product is given. There are also various formats and requirements that must be followed when compiling the dossier and they are composed of 5 modules, with each module containing specific information. This whole submission process is highly critical for pharmaceutical and life sciences companies, ensuring compliance with stringent regulatory standards and facilitating the safe introduction of new therapies to the market.
Traditional Workflow- Navigating the Regulatory Maze:
In the conventional landscape, Regulatory professionals navigate through extensive documents, ensuring alignment with the stringent requirements of health authorities. This manual approach consumes time and amplifies the risk of errors, potentially causing delays in product approvals. Research undertaken by International Society for Pharmaceutical Engineering has reported on the complex challenge that surrounds the workload very apply through the image below-
Challenges that lead to delays in approval, International Society for Pharmaceutical Engineering
Statistics Speak the Toll of Traditional Processes
- Traditional workflows demand an average processing time of several weeks, causing delays in bringing crucial therapies to market.
- Manual dossier review processes bear an error margin ranging from 5% to 10%, posing risks to regulatory compliance and patient
- Conventional methods contribute to high operational costs, with expenses reaching up to 50% of the total budget for regulatory
But With AI taking over the world and how, Pharma companies and regulatory bodies can benefit from automating their dossier submission and transcending the limitations of traditional workflows, introducing a paradigm shift in regulatory affairs through expedited submission and little-to-no error and human intervention. So let’s understand how this will actually be the catalyst of change.
Automated Dossier Due Diligence: Precision at Scale
Dossier Due Diligence Automation leverages a robust AI/ML framework to conduct meticulous checks across different modules (1 to 5). The result?
- Automation of complex data collection: A process that is not only automated but scalable, ensuring accuracy and efficiency even in the face of large and complex datasets
- Omnichannel communication management: You can also streamline entire communication across stakeholders by automating your Business Notification & Query Management This functionality seamlessly
integrates with the regulatory adherence process, assigning queries while attaching pertinent dossier details. This ensures a streamlined communication channel, reducing the risk of oversight and expediting query resolution
- Customizable Workflows with Intuitive UI: Flexibility is key in the world of
regulatory affairs. With AI at the driving seat you have potential to also embed customizable workflows, aligning with the unique processes that only cater to your business.
Estimates say that adopting AI for Dossier Due Diligence can slash processing time by up to 60%, enabling faster submissions and accelerating time-to-market. Not just this, but:
- With AI at the helm, the margin of error diminishes to less than 1%, ensuring precise and compliant submissions.
- Companies leveraging AI for Dossier Submission report a significant reduction in operational costs, with potential savings of up to 40%.
In the intricate world of regulatory affairs, “Dossier Due Diligence Automation” emerges as a transformative partner, infusing precision, speed, and reliability into the traditional fabric of Dossier Submission. The statistics, the workflows, and the user interface collectively narrate a story of innovation, efficiency, and a future where AI propels regulatory affairs into uncharted territories.
Someone very rightly remarked that- “If compliance is expensive, try non-compliance and as we embrace this technological evolution, the question lingers – will you be a spectator or a protagonist in this unfolding narrative of progress? The stage is set, and the spotlight is on “AI based Dossier Due Diligence Automation” – the game-changer in the regulatory landscape.
