10 Small Submissions
No more than 10 Documents per submission
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.
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.
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.