The process of preparing and submitting labeling to regulatory authorities can be time-consuming and complex, requiring specialists’ input and careful coordination across organizations and functions to ensure the quality and safety of products going to market. This often causes delays that ripple across the supply chain, impacting profitability and patient care. Coupled with the need to meet evolving requirements across global markets, it is no surprise that achieving effective label management remains a major challenge for many life sciences organizations.
Thankfully, technological advancements are helping to transform these challenges into opportunities for greater efficiency and precision.
1. Accelerating the submissions process
One of the biggest hurdles in pharmaceutical labeling is the lengthy submissions process: collecting the necessary data, going through rounds of stakeholder reviews, and submitting to local authorities. These steps can significantly delay a product's entry into the market, slowing a company’s supply chain, limiting profitability, and keeping transformative treatments away from the patients who need them.
To combat this process complexity, life sciences organizations are investing in solutions with task automation and intelligent process orchestration capabilities. These systems help accelerate submission timelines by automating repetitive tasks, sending timely notifications to stakeholders, and providing a seamless user experience. This ensures that the right people review and approve content promptly, reducing the time lost in coordination and manual oversight.
2. Minimizing resubmissions
Resubmissions can be both costly and time-consuming, especially when regulatory requirements differ across markets or if errors arise in the submission process. Many of these resubmissions can be avoided if submission packs are properly prepared from the start, with the right documents for each specific market.
An automated solution can help tackle this challenge by bundling content based on business rules and local market needs. It can automatically capture review notes and key decisions, ensuring that the right documents are included, which in turn can reduce the risk of errors or omissions that trigger resubmissions. This precision in submission preparation not only cuts costs but also saves valuable time, allowing pharmaceutical companies to focus on innovation and product development.
3. Enhancing traceability
The complexity of pharmaceutical labeling doesn’t end with submission. Labeling activities, approvals, and subsequent changes need to be carefully logged and fully traceable to ensure compliance and easy audits. Centralizing this data is also critical for streamlining downstream processes, such as supply chain oversight and artwork management.
Appian offers a solution that enables access to critical data and documents within a single interface, accelerates decision-making processes, and improves efficiencies throughout the production lifecycle. By maintaining a clear record of decisions and reviews, companies can optimize their regulatory submissions with continuous process insights, driving improvements in quality and efficiency over time.
Appian for labeling
Pharmaceutical labeling is a crucial, yet often cumbersome, process that has far-reaching impacts on a company’s success and the well-being of patients. By leveraging a modern solution like the Appian Platform, companies can transform their labeling processes, reduce submission delays, and enhance traceability, often resulting in the prevention of costly resubmissions. These innovations not only improve regulatory compliance but also help companies bring life-saving treatments to market faster—ultimately benefiting both the industry and the patients they serve.
