Regulatory Processes done right.

Software for IDMP Pharmacovigilance.

eCTD Submission.

Regulatory Information Management.

Our integrated regulatory master data management software is provisioned as SaaS (Software as a Service), follows best practices for pharmaceutical and life science companies and guarantees compliance with 100% customer satisfaction.


Benefits for our customers

Cut submission time

Cut submission time

…through seamless integration of document management functionalities and submission tools, such as automatic creation of the submission tree, automatic document placement and web based sharing capabilities. – „Autocompile“ function.
Cut audit preparation time

Cut audit preparation time

…by leveraging automatic tracking of all training results across the organization. No Excel or Word report compilation required.

Increase Working Speed

…by providing users with unique process optimization features. Parallel real time collaboration via a convenient document sharing function – selective content can be shared securely within minutes.

Project Roi within 6 months

…by reducing the implementation time to hours instead of months. This is made possible as industry best practices are already implemented within the system instead of being made through constant project reengineering. This results in “One Click” deployment.

Save 30-50% in license costs

…by utilizing monthly subscription fees and ensuring that the software is constantly updated and validated to industry requirements.  No need to pay for costly maintenance, updates or endless consultants.

Reduce maintenance costs

…through implementation as a real multi tenant cloud system. Customer data is strictly separated but all software upgrades and maintenance work are included within the user fee structure.

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

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

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

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

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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

Regulatory has never been easier.

Tailor-made solutions for Pharma and Life Science Industries

Apis and Generics
Creating, 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!

Bio Pharma and Biotechs
Producers 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.
Regulatory 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.
Medical Devices
Should 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

Tracey Burr, Chief Scientific Officer Polymed Therapeutics
Excellent value for money. The most effective eCTD and DMS system, I have ever seen. Remarkable customer support.
Anja Karstens, Regulatory Manager ak MDRA
The Cunesoft online software for electronic submissions and document management is ideal for regulatory consultants such as myself.
Richard Needham, Regulatory Expert RFL Associates
Finally a provider of regulatory software with an affordable business model suitable for smaller organizations and emerging market organizations.
Stacey B., former Senior Manager Regulatory Affairs UCB Pharma
Cunesoft offers a single system that handles my documents, submissions and correspondence tracking. It’s great!
Andreas Vogel, Regulatory Affairs Directory Laboratories CTRS
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.

Contact us and enjoy a FREE Demo