Life Sciences is one of the most highly regulated industries, given its impact on human health. Organizations must comply with complex regulations throughout the lifecycle of a drug – from development to approval and from manufacturing to safety. At the heart of this lies the regulatory submissions process, a critical function that ensures the safety, efficacy, and quality of pharmaceutical products.
Yet, many companies still rely on outdated, manual methods to manage this process. As the volume and complexity of data increases, so do the challenges of staying compliant and competitive. That’s where workflow automation, and increasingly AI can make a meaningful difference.
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Inside Today’s Regulatory Submissions Process
Why manual tasks slow you down
The regulatory submissions process involves a lot of moving parts – data entry, document handling, collaboration, and reviews across teams. Most of this still happens manually.
Global teams often work with disconnected systems and rely on email or shared drives to manage updates. This leads to duplicate work, document version mismatches, confusion over the latest updates and slower approvals. As submission demands grow, these gaps make it harder to stay compliant and on schedule with the current tech stack.
How process automation streamlines regulatory submission workflows
Here is a typical Regulatory Submissions process observed across various clients in the Life Sciences industry.
The process involves multiple stakeholders executing their tasks within a structured framework of business rules that influence decision-making. It encompasses several layers of review and approval, with an emphasis on quality assurance and governance at each stage. Strict adherence to GxP guidelines is essential, along with maintaining a comprehensive audit trail, accountability, and traceability.
What Automation Can Do for Regulatory Submissions
Transform your process with speed, structure, and visibility
When applied to regulatory operations, process automation platforms like Appian help teams add connectivity, structure and transparency to legacy regulatory applications. Combined with AI, process automation makes submissions not just faster, but smarter.
Here are a few ways Process Automation enhances the end-to-end submission lifecycle:
Document Identification and Collection
Easily locate required documents from various systems. Process Automation uses flexible business rules that users can configure to ensure the right data and files are collected on time.
AI adds another layer by using Natural Language Processing (NLP) to read and understand unstructured content (like study reports or correspondence) and surface a summary and/or only the relevant sections needed for a submission package.
Document Review and Approval
Workflows route documents to appropriate stakeholders in regulatory affairs, clinical research, and quality assurance. You can easily build approval hierarchies and audit trails, so you always know who signed off and when. AI can act like an extra reviewer, spotting anomalies in data tables, flagging inconsistent terminology, or even suggesting edits for regulatory language to align with specific agencies.
Submission Package Assembly
Process Automation can compile submission-ready packages using only the latest approved versions, reducing manual effort and ensuring consistency. With AI, teams can identify the most relevant templates and content based on past submissions, saving time and avoiding repetitive work.
Regulatory Compliance Checks
Automated workflows verify that each submission meets specific health authority requirements. You can check for formatting, completeness, and country-specific needs with ease. AI can additionally scan against evolving global regulations (FDA, EMA, PMDA , etc.) and highlight areas where requirements have changed, so teams aren’t caught off guard.
Real-Time Status Tracking
Managers and leaders can view real-time dashboards showing progress, bottlenecks, and ownership. These dashboards can be proactive rather than reactive. For example, they can identify tasks at risk of delay before they happen, instead of showing them after they are delayed. This allows managers to take preventive actions to avoid delays. You can also ensure that the latest approved documents are always included in the final submission. With AI, you benefit from predictive insights like which sections are likely to cause delays or which submissions may face a higher risk of queries based on historical patterns.
Audit Trail and Governance
Every action is logged automatically, providing full traceability. This makes it easy to respond to audits or queries from regulators.
Submission and Follow-Up
Once teams submit a docket electronically to the health authority, process automation can support them with tracking mechanisms and follow-up workflows, reducing the risk of missed deadlines. With AI, teams can also respond faster to regulator queries in natural language, surfacing the right data and documents at the right time.
Why Automation Matters for Regulatory Submissions
Business outcomes that move the needle
Workflow automation does not just simplify tasks. It also delivers tangible business value across your regulatory operations.
Faster Time-to-Submission
Process Automation accelerates document tracking, review cycles, and final packaging. Regulatory teams can move submissions through approval hierarchies faster, without chasing emails or manually checking status. Clinical and safety data flows in directly from systems like CTMS and EDC, reducing time lost to coordination.
Higher Submission Quality
Automated compliance checks verify completeness, structure, and formatting based on configurable business rules. Quality and compliance teams gain confidence that every submission aligns with regulatory expectations, reducing the risk of rework, delays, or rejection.
Greater Operational Efficiency
Instead of building each submission from scratch, teams can reuse approved content, templates, and workflows. This repeatability frees up bandwidth for high-value work and allows clinical, regulatory, and quality teams to focus on strategy and not administration. AI can recommend reusable modules, predicts the effort required for new submissions, and helps allocate resources more effectively.
Real-Time Visibility and Control
Dashboards give managers and leaders a live view of submission progress, bottlenecks, and task ownership across global teams. They can track readiness, identify risks early, and ensure accountability, all without needing to follow up manually. AI enriches this with forecasts. e.g., “this submission has a 70% chance of delay due to missing clinical data,” so teams can act early.
Enhanced Cross-Functional Collaboration
With everyone working on a unified platform, cross-functional teams stay aligned throughout the submission lifecycle. Regulatory affairs, clinical research, safety, and quality assurance teams can seamlessly share the latest documents, track comments, and ensure that only the latest approved versions are included in the final package.
Improved Regulatory Readiness
Automation ensures consistency, traceability, and governance. Whether you’re preparing for a new submission or responding to a health authority query, you can act quickly, with confidence in your data, documents, and audit trails.
From Process Friction to Competitive Advantage
Life sciences companies face increasing pressure to accelerate innovation without compromising safety or compliance. But in reality, the legacy systems that enable the core clinical and regulatory operations of a pharmaceutical company are often disjointed and operate in silos. They are rigid in adapting to changing regulations, resulting in manual work being done on Excel sheets and point solutions. This hinders productivity and increases risk.
This is where Appian makes a difference. It bridges the functional gaps left by legacy systems and improves interconnectivity between them. That leads to a unified, agile environment for regulatory operations.
And with the right Appian partner, companies can go a step further. A skilled partner helps tailor Appian’s powerful features and functionality to the unique challenges of the business, ensuring the platform is not just implemented, but optimized for impact.
Process Automation plus AI offers a strategic advantage in connecting people, processes, and data across the submission lifecycle. Companies can empower their teams to work faster, collaborate better and maintain compliance with confidence. This approach helps you leverage your investment in the existing legacy systems while giving your business teams the ability to collaborate and have a unified view of data across these systems.
Whether you’re a regulatory affairs lead, clinical operations manager, or quality director, the benefits are clear: streamlined processes, real-time visibility, and a faster path to approval.
Watch Demo: Automated Regulatory Submission in Action
Princeton Blue’s Regulatory Submissions solution automates the processing of creating, approving, and submitting various types of regulatory documents using the Appian Low-code Process Automation technology. Watch a demo here >
If you’re interested to learn more, send us a message >
