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.

As part of its RPA strategy, Merck leveraged unattended bots from Automation Anywhere to automate and streamline the creation, management, and distribution of its regulatory processes. 

“The initiative began in 2021. We started with the APAC region and then scaled up the solution to Latin America and the US regions. It took us two years to implement the solution. By the time the project ended in December 2022, we had covered 23 geographies and 43 processes, including trade compliance, cross-country logistics, and regulatory management,” says Mahadev.

As part of its RPA solution deployment, Merck has cloud-based on-premises development and production control rooms.

“In the development control room, there are 25 users with different roles. In the production control room, there are around 150 users with different roles assigned. As it is a cloud-based system, users launch the development/production control room URL in any of the browsers and log in to their user accounts,” says Ankur Kothari, co-founder and chief customer and strategy officer of Automation Anywhere.

For Mahadev, obtaining approval to automate regulatory processes itself was a “herculean task as we were handling the most crucial and important regulatory processes in the value chain of getting go-to-market approval. Every process flow chart was reviewed by the assigned business board members,” she says.

“The IT teams framed new SOPs [Standard Operating Procedures] to give restricted access to the bots on the production system, unlike human user access. Every bot is mapped to unique IDs to track their activity by the IT team at any time,” Mahadev says.

“So far, we have delivered more than 130 bots using the automation solution by automating SAP, Oracle, Web, Windows, Desktop, Office365 applications, Salesforce, PDF, email, FTP servers, APIs, and so on,” she says.

Increased top line, reduced resource hours

By automating manual processes, Merck has saved crucial time, which can now be used for more meaningful tasks.

“Regulatory SMEs [subject matter experts] from 23 geographies can now focus on higher-value operations by delegating monotonous chores to RPA. It enhanced the accuracy level and compliant by on-time submission of the regulatory documents. It helped us save 121K human hours, allowing us to allocate more time toward other valuable tasks,” Mahadev says.

A huge chunk of pharma sales representatives’ time is spent in tracing the right set of people to contact and then manually entering their credentials and/or content provided. This leaves little time for them to interact with patients, healthcare practitioners, and administrators.

By leveraging bots, sales representatives can retrieve accurate and timely sales data, manage inventory orders, track customer feedback, and engage in activities that need persuasion and communication skills.

Automation bots can also help with inventory management. They can prevent running out of stock or overstocking by tracking shipments, automating invoices, citing delays, and alerting when drugs near their expiry dates.

The solution has aided in improving Merck’s go-to market strategy as the commercial team was able to release the block orders on a timely basis. This effectively enhanced revenue generation through the commercial teams.

“This will enable us to increase our product sales by millions of euros over the next five years, based on commercial projections, as well as meet commercial key SKU import initiative and fulfil the Stock Keeping Units replenishment requirements in the long term. It will also help the supply chain team’s target of on-time product deliveries,” says Mahadev.

On the future of automation at the company, Mahadev says, “Merck is looking forward to the cognitive capabilities. Handling unstructured data and the decision-making process are the need of the hour. Improvements in cognitive capabilities might be beneficial in shifting the focus away from rule-based automation and toward unstructured data.”