The pharmaceutical industry is a highly regulated one, especially for multinationals doing business across the globe.
The regulatory process for pharmaceutical firms involves complex activities linked to various value chains — collecting data, applying for the right license, generating supporting documents for submission, and supply chain operations — that aid in the timely tracking of orders and the smooth passage of customs in respective nations, depending on the regulations involved. The firms’ trade compliance teams must not only engage with all these processes but ensure they are aligned with ever-increasing regulations, which can differ notably from country to country.
Although non-compliance with regulations can attract exorbitant fines, many pharma companies still depend on manual process for these value chains. Merck Life Sciences, a leading chemical and pharmaceutical company, with 60,000 employees working across 66 countries, was one of them.
“Dependency on human resources is both time-consuming and fraught with errors. Automation of regulatory processes in the pharmaceutical and biopharma industry is important to reduce human error and automates repetitive and complex activities,” says Dr. Radhika Mahadev, head of robotic process automation (RPA) at Merck Life Science.
“To increase efficiency while working on various regulatory processes that assist in compliance through on-time submission of the regulatory documents, cost, improving performance, and enabling a speedy go-to-market timeline, we decided to leverage RPA,” she says, an increasingly popular approach to automating business processes.
Streamlining regulatory processes
RPA leverages software bots to capture and interpret actions involved in completing a given business task, including inputting and manipulating data, triggering responses, and communicating with other systems. By emulating these actions previously taken by humans, RPA bots help automate business processes, reducing errors and freeing up workers for higher-level tasks.
