Case Study

SARA Project

Leadvise Reply supported the leading science and technology company Merck Healthcare KGaA in the realization of the CPhI Pharma Award-winning project SARA (Smart Assistants for Regulatory Affairs).

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The Regulatory Affairs Operations department of the Merck Healthcare division is responsible for applying for and maintaining regulatory approvals and therefore liaises with regulatory authorities such as the EMA or the FDA. The award-winning project SARA analyzed existing processes and identified those that would benefit most from automation.

On the basis of the information obtained, the processes were then improved and automated using software robots. A particular feature of the project is the concept of rapid prototyping, which uses the results of process mining to make fact-based, unbiased decisions.

On average, Merck submits a document to one of the regulatory authorities worldwide for review every 15 minutes. These necessary data processing and submission processes have now been successfully accelerated. In addition, the goal of relieving employees of repetitive, strenuous tasks through the use of RPA was achieved.

Leadvise Reply supported the department to realize solutions using Process Mining, Robotic Process Automation (RPA) and Text Mining to enable the team to meet the constantly changing regulatory requirements.


Leadvise Reply specializes in management consulting with a focus on highly regulated industries such as telecommunications, chemicals, pharmaceuticals or the banking and stock exchange environment. Leadvise Reply supports companies in strategy, organization and implementation projects using advanced technologies such as Robotic Process Automation or AI.