Streamlining Regulatory Submissions Through Data

Pharmaceutical professionals in the Regulatory space face complicated, rigorous, and ever-evolving requirements for the Regulatory approval of products in any market. But as technology advances, our ability to obtain data from other sources also changes. The amount of data in the Life Sciences industry is rising exponentially. The rise of the required information within Regulatory submissions occurs due to the fact that patients can have safer and more effective treatments coming into the market. However, creating the documentation is a laborious challenge that can’t be solved by just increasing the team size. Therefore, outsourcing and automatic data analysis are vital for every enterprise.

Evolution of Regulatory Submissions

Years ago, paper documentation that needed to be submitted for a new drug product approval would be huge, while today, it is electronic and very well-organized formats are available. The life cycle of Regulatory submissions evolved immensely over the years. As more and more processes have become tech-savvy, the fact that people are working in silos has become more of a hurdle than ever. The adoption of structured content is a major transformation for Life Sciences companies whose Regulatory processes have been conventionally focused on paper document submissions due to compliance. This change began to regain impetus when the pandemic forced companies to shift to a distant operations model.  While considerable development has been made in the last two (02) - three (03) years to integrate Regulatory submissions across organizations, more is still needed, as it is important to ensure data uniformity across all submissions.

Data Benefitting Regulatory Submissions

• Sharing and reuse of data cannot just be limited internally but also be extended to external partners across multiple countries. If a single product can be launched in ten (10) different markets by repurposing 90% of data that would be the same, it results in a huge increase in productivity.
• Smart templates pull information from integrated data sources to assemble the Regulatory document, a breakthrough method to streamline the Regulatory submission processes, thereby bringing products faster to the market.
• The information gathered in the form of data would be formatted and entered correctly into the databases for use. This ensures a high-quality dossier.
• As there is uniformity of data and the submission process is streamlined, there is an increase in transparency, which minimizes the chances of errors, thereby accelerating the submission process.
• As the process is fast and smooth, it eventually brings down the cost of submissions and publishing, creating a win-win situation for the organizations.

To conclude, companies should take time to plan their strategy well. Organizations must adopt data and automation technologies that will change operations and speed up electronic Regulatory submissions. With Regulatory expertise and the power of automation, the data is curated and validated for end-users to access insightful and relevant information that can be accessed through a sharable rich visual interface.

Freyr is at the forefront of driving innovation through advanced tech-enabled products such as Freyr SUBMIT PRO. Partner with us today to bring in the right mix of process expertise and tools that enable you to streamline your Regulatory submission operations and achieve better productivity & submission quality.