Regulatory Processes done right.

Content Analysis Framework / Data Mining

Designed specifically for Life Sciences companies, the Content Analysis Framework from Cunesoft is optimized to enable comprehensive data extraction from large volumes of documents.

Regulatory Operations Platform (eCTD, DMS, IDMP, RIM, SOP)

Sophisticated yet simple to use, the Regulatory Operations Platform from Cunesoft is build on industry best practices for Life Sciences companies and delivered as Private SaaS (Software as a Service).


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What we offer you

We Offer Regulatory Compliance Software and Services




Regulatory master data management for the preparation, management and submission of ISO IDMP compliant and xEVMPD submissions. read more



Create, review, approve and sign submission related documents according to FDA 21CFR part 11 requirements. read more



Create new or import existing electronic submissions and compile all types of eCTD submissions including eCTD lifecycle management. read more



Manage Standard Operating Procedures (SOP’s) from beginning to end. Distribute to employees and automatically track training records. read more



Create your own submission data base, track all regulatory events and include authority correspondence in one comfortable system. read more



Automatically extracts data from SmPCs and xEVPRM messages. Detailed data elements about the medicinal product name, clinical particulars, package medicinal product and marketing authorization are automatically extracted from uploaded input files. read more

“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.”

Rainer Schwarz – CEO and Founder, Cunesoft

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Benefits for our customers

Regulatory has never been easier.

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Tailor-made solutions for Pharma and Life Science Industries


cune ECTDCreating, editing and migrating submissions is easy with our eCTD module in combination with the Regulatory Document Management Module. Managing your ASMF, DMF and other Sumbission types was never easier! Moving from paper to electronic submissions is quick and easy with the Cunesoft regulatory suite!

ectd software supportProducers of originator drugs or Biotechnology companies face the challenge to reduce R&D time as much as possible. Electronic submissions to gain market approval by authorities can securely be handled by Cunesoft’s eCTD Module in combination with the Regulatory Document Management Module. Ideal for Biotechnology companies to manage quality compliance can be provided with Cunesoft’s lean SOP management software.

SOP SoftwareRegulatory service providers in most cases cannot afford hosting a regulatory software for electronic submissions, quality management and clinical trials management. On the other hand their customers require results that have been created under regulatory compliance aspects. Cunesoft’s online Software as a Services (SaaS) concept provides an ideal base to manage compliance and offer their customers a collaborative platform to manage regulatory documents, electronic submission types such as eCTD’s and share quality documents such as SOP’s with them.

regulatory softwareShould you require help to produce your premarket notification 510(k) or the premarket approval (PMA) as eCopy then our outsourcing service team can help you. Furthermore the Cunesoft SOP and Training Records Management module are ideal to manage quality processes according to GMP and GDP requirements.

Happy Customers With Cunesoft

Excellent value for money. The most effective eCTD and DMS system, I have ever seen.
Remarkable customer support.

Tracey BurrChief Scientific Officer - Polymed Therapeutics

The Cunesoft online software for electronic submissions and document management is ideal for regulatory consultants such as myself.

Anja KarstensRegulatory Manager - ak MDRA

Finally a provider of regulatory software with an affordable business model suitable for smaller
organizations and emerging market organizations.

Richard NeedhamRegulatory Expert - RFL Associates

Cunesoft offers a single system that handles my documents,
submissions and correspondence tracking. It's great!

Stacey B.former Senior Manager Regulatory Affairs - UCB Pharma

We were choosing Cunesoft because it provides us with an end to end regulatory operations software. It was fast to implement, is easy to use with a great ROI.

Andreas VogelRegulatory Affairs Directory - Laboratories CTRS

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