Regulatory Software Company Cunesoft flies high with its AI approach

Cunesoft provides intelligent regulatory software as a service based regulatory compliance solutions for life sciences industries internationally. It offers a modular concept to manage the product lifecycle end to end. A workflow driven software platform manages documents, data and submissions.

All processes have been designed from an industry best practices perspective and enable out of the box compliance with FDA, EMA or other health authority requirements around the globe.

Unique within Cunesoft’s technology are intelligent algorithms woven into the process. The system can read and data mine documents. It can interpret data and suggest tasks and events based on predictive analytics.

Established in 2013, Cunesoft is based in Munich, Germany with international offices in Princeton, NJ, Paris and Bangalore.

Interview Excerpt: Rainer Schwarz, CEO Cunesoft

Talking to The Silicon Review, Rainer Schwarz reveals that the pharmaceutical industry, like other regulated industries - be it chemistry, aerospace or banking - is still characterized by paper-intensive, manual processes.

“We have set ourselves the goal of speeding up and automating processes in regulatory industries. Our intelligent self-learning software for regulated workflows can save up to 80% of process time. For example, the software automatically builds up the application for a drug approval on the basis of the available data. The human being then only needs to release the proposed work,” Schwarz said.

When everyone is in the loop: Rainer Schwarz

The CEO asserts that the business had more of a chance to be ahead of the curve. Hence, the company recruited manpower across the nations.

“If you offer a solution that provides unique value, the word of mouth spreads very fast. A large number of companies wanted to purchase our software and they did. Subsequently, we gained recognition in all spheres, resulting in more customers were approaching. We could not deal with such numbers of customers including Astra Zeneca, GSK, Avacare, Valspar and many others by ourselves anymore. Therefore, we needed to hire more people to keep the momentum going. And now there are people working for Cunesoft all over the world,” the CEO asserts.

“The company is still young but its potential is tremendous. In future, our high level of innovation will have a positive effect on the health of millions of people across the globe,” he said.

Make sure everyone is on the same page: Rainer Schwarz

While hailing his team, Schwarz reveals that networking is an effective yet low-cost marketing method for developing sales opportunities and contacts.

“Without our splendid, trained teams all across the world, Cunesoft might still be just one lonely office in Munich, but now – the company has spread its wings. Another very important asset that helped us to grow tremendously is the compliance domain knowledge – this is the market where not everyone could enter because of its complexity. Although I am very happy that we took this brave step,” Schwarz said.

“Many times situations arise at which the organization deviate from its original focus. For instance, a customer might want a certain legacy solution – which may not be available at the moment. Or a sales partner comes with a business opportunity outside of the current scope. Therefore, staying focused is very critical,” Schwarz said.

Raising the bar

Cunesoft is excited to deliver an artificial intelligence user interface, called VERA – the company’s virtual electronic regulatory assistant. This virtual assistant automates process steps, assigns tasks, monitors results and helps to speed up and automate process steps. VERA is a part of the company’s regulatory operations platform. “Such innovation will place regulatory affairs into another dimension, where the work is more precise, faster and easier to control. VERA is an assistant with your everyday regulatory needs. Cunesoft is the first to provide such intelligent algorithms,” Schwarz claims.

About the CEO – Rainer Schwarz

Rainer Schwarz is the CEO and one of the two founders of Cunesoft. He has held senior management positions at CDC Solutions, Liquent and NextDocs. Schwarz has worked in the area of software solutions sales for the past nine years, predominantly selling to the life sciences industry. Prior to NextDocs, Schwarz spent four years as European Sales Director for Liquent/Thomson-Reuters. He holds a Master of Social Sciences from the University of Innsbruck and Hong Kong University.

“Your regulatory affairs role is vital to the development, registration and marketing of all drug products. Cunesoft’s role is to help you manage regulatory activities in the most efficient way possible. Our world needs your products quickly. Let’s work together to achieve this.”

Get in touch : http://cunesoft.com/