What we do

Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our software has been built to fulfil regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.

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Holly Harvey - Assistant Project Manager

Donna Whiting - Client Success Manager

Chethan Chandrappa - Software Developer

Dr. Ganesh Singh - Director Product Management

Julian Schloßmacher - Marketing Director

Rainer Schwarz - CEO

Neringa Antanaitytė - Assistant Marketing and Administration

Naveen Navalay - Software Developer

Daniel Koppers - CTO

Jim Nichols - VP Life Sciences, North America

Holger Telgen - Software Engineer

Rajendra Prasad - Software Developer

Sophie Guillaume - Regional Manager France & Western Europe

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Who we are

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We rely on a great team!

The regulatory hurdles faced by Life Sciences companies are sometimes viewed as slowing progress. The reasons for this are compliance requirements that are being provided by health authorities to ensure patient safety and to ensure product quality. While this is perfectly fine, the consequence is that these regulations are so severe, that achieving compliance leads to very slow processes.

At cunesoft, our vision is to provide intelligent automation to these processes so that our clients are better able to address the growing need for new and personalized medicines – without requiring more regulatory manpower than today. Ultimately, by helping our clients speed up their regulatory operations, better medicines will become available and mean better lives for our global community.

Rainer Schwarz

Rainer Schwarz

CEO

15 years experience with compliant software solutions for regulated processes
Senior management positions at CDC Solutions, Liquent and NextDocs
Master of Social Sciences from the University of Innsbruck and Hong Kong University

Daniel Koppers

Daniel Koppers

CTO

More than 7 years experience with software development and project management
Deep knowledge of life sciences and regulated industries, previous employers include Nextdocs and Adlib Software
Degree in Business Informatics

Martin Olczyk

Martin Olczyk

CFO/COO

6 years experience in technology investment banking
Previous employers include IEG Investment Banking and Angermann M&A International
Degree in economics from the University of Tuebingen

Jim Nichols

Jim Nichols

VP - Life Sciences, North America

15 years’ experience with compliant software solutions for regulated processes
Senior management positions at Liquent, Thomson Reuters and DitaExchange
Bachelor of Science in Mathematics from The Pennsylvania State University

The challenge of joining regulatory compliance with rapid approval is one that I enjoy facing and being a part of the solution.

Jim N.Vice President Life Sciences, North America

We offer a great product with value for our customers. Working in an innovative environment is a great pleasure and an it is an amazing experience to be in touch with global clients.

Holger T.Developer

It is amazing how good software and the right services make customer happy. I enjoy speaking to satisfied clients every day.

Neringa A.Marketing

The regulatory industry is a very complex environment. At Cunesoft our job is to design products which simplify these structures and empower our users to keep control at any given moment.

Julian S.Marketing

I enjoy it everyday, to see our happy clients using our software. I am very proud to contribute to our SaaS solutions success.

Marie P.Software Testing

We do our best to provide our customers with highest standards and ongoing improvements of our software modules. We are happy when our customers are happy.

Rajendra P.Software Development

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