The Life Sciences industry is one of the most highly regulated industries, given its impact on human health. Pharmaceutical companies need to comply with complex regulations throughout the lifecycle of a drug – from development to approval and from manufacturing to safety. The regulatory submissions process plays a crucial role in maintaining compliance with these regulations.
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The regulatory submissions process involves preparing and submitting documentation to regulatory authorities for approval and ensuring compliance with laws for life sciences products. It involves meticulous compilation of data, documentation, and evidence required to ensure pharmaceutical products’ safety, efficacy, and quality.
In this blog post, we delve into the realm of regulatory submissions within the pharmaceutical industry, exploring the challenges faced by organizations in the current landscape. We then turn our attention to workflow automation and data integration, and the potential for these modern low-code technologies to innovate in the regulatory submissions process.
Through a detailed examination of workflow automation and data integration’s benefits for regulatory submissions, we shed some light on how pharmaceutical companies can successfully navigate the complexities of regulatory submissions with greater ease, efficiency and transparency.
Current State of the Regulatory Submissions Process
The regulatory submission process within the pharmaceutical industry is characterized by its manual nature, complexity, and the myriad challenges it presents to pharmaceutical companies.
Traditionally, these processes are non-standardized and often involve labor-intensive manual tasks, such as data entry, document handling, collaboration, and review, contributing to inefficiencies and the potential for errors.
Navigating regulatory requirements and standards are complex when done manually, especially in cases where there are parallel versions of submissions and data in disparate systems.
Addressing these challenges requires a holistic approach that brings systems, people and data together and automates workflow and collaboration, while still maintaining the investments in your company’s current systems.
By streamlining processes, integrating data across systems, enhancing collaboration, and ensuring compliance, pharmaceutical companies can navigate the complexities of regulatory submissions with greater efficiency and confidence.
What does a streamlined and automated workflow for regulatory submissions look like?
An automated internal workflow for regulatory submissions (to regulatory authorities like the FDA) streamlines the entire process, from document creation to submission. Here’s an overview of such a workflow:
- Document Identification and Preparation:
- The process begins with the identification and preparation of regulatory documents required for submission, such as clinical trial data, drug development reports, and safety assessments.
- Automated document identification automates and standardizes document creation, driven by flexible business rules that business users can easily configure, thereby ensuring consistency and compliance with regulatory standards.
- Document Review and Approval:
- Once the documents are created, they undergo a review and approval process involving various stakeholders, including regulatory affairs, clinical research, quality assurance, and other teams in the drug development process.
- Automated workflows route documents to designated reviewers based on predefined rules and approval hierarchies. Reviewers can access documents electronically and provide feedback or approval within the system. No more lost emails or tasks!
- Data Integration and Analysis:
- Data from various sources, such as clinical trials, preclinical studies, and manufacturing processes, are integrated into the submission documents.
- Automated data integration facilitates the aggregation, analysis, and validation of data, ensuring accuracy and completeness before submission. This helps bring data from legacy systems into the context of the regulatory submission process.
- Regulatory Compliance Checks:
- Automated compliance checks are performed to ensure that submission documents adhere to regulatory requirements, guidelines, and formatting standards.
- Validation rules and checks are implemented within the workflow to flag any discrepancies or non-compliance issues for resolution.
- Document Tracking and Version Control:
- Throughout the submission process, automated tracking mechanisms monitor the status and progress of documents. This helps provide a high-level picture of the process to managers and leaders.
- Version control features ensure that only the latest approved versions of documents are included in the submission package, preventing potential errors and confusion.
- Submission Assembly and Compilation:
- Once all documents are reviewed, approved, and finalized, the automated workflow assembles and compiles them into a submission package.
- Automated tools assist in organizing, indexing, and formatting the submission package according to regulatory requirements.
- Tracking and Follow-Up:
- Once a docket is submitted to the health authority, tracking mechanisms can help monitor the status of electronic submissions and provide alerts or notifications for any requests for additional information or queries from regulatory authorities.
- Automated follow-up processes done internally facilitate timely responses to regulatory inquiries and ensure compliance with post-submission requirements.
Overall, an automated workflow for regulatory submissions streamlines submission planning and regulatory documentation by reducing manual effort, improving accuracy and compliance, and accelerating the time to market for pharmaceutical products.
Benefits of Workflow Automation on the Regulatory Submissions Process
By reducing manual intervention for repetitive tasks, regulatory affairs leaders can allocate resources more efficiently, focusing on higher-value activities such as regulatory strategy and compliance oversight.
Additionally, automation accelerates the submission timeline, enabling faster time-to-market for pharmaceutical products and reducing associated costs.
The following gains can be seen immediately:
- Improved Efficiency: Automation eliminates manual tasks, reducing time and effort spent on repetitive administrative processes. By automating data entry, document handling, and other routine tasks, workflow automation accelerates the submission process, enabling pharmaceutical companies to meet regulatory deadlines more efficiently.
- Integrated Data: Workflow automation integrates disparate systems used in the submission process, providing seamless access to data in the context of the workflow. By centralizing data sources and eliminating data silos, automation ensures data consistency, accuracy, and accessibility across the submission lifecycle. This integrated approach enhances data integrity, simplifies information retrieval, and facilitates informed decision-making. Read more about this on our data integrity in the pharma industry article.
- Enhanced Collaboration: Centralized platforms provided by workflow automation tools facilitate seamless communication and collaboration among stakeholders involved in the submission process. Real-time access to documents, tasks, and updates streamlines communication channels, enabling faster decision-making and alignment across teams.
- Compliance Assurance: Workflow automation enforces standardized processes and controls, ensuring compliance with regulatory requirements and industry standards. By embedding validation rules, approval workflows, and audit trails into automated processes, pharmaceutical companies can maintain data integrity throughout the submission lifecycle.
- Visibility and Reporting: Workflow automation provides real-time tracking and reporting capabilities, offering stakeholders visibility into the status and progress of regulatory submissions. Customizable dashboards, analytics, and reporting tools enable better decision-making by providing insights into submission metrics, bottlenecks, and trends.
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 >
Princeton Blue’s EU-CTR solution aims to streamline and automate the internal workflow process to create a set of documents for submission/transition under the new EU-CTR guidelines. Learn more >
If you’re interested to learn more, send us a message >
