Biomedion - your changemaker in the life sciences industry

the data supply chain

biomedion's neuronos as the preferred gear for your GxP data

neuronos is the trusted gear for scientific data for the healthcare, medical research and pharmaceutical environment - Maintaining an intelligent data supply chain from the very first bit until long-term archiving. The pharmaceutical industry is actively exploring our technologies to solve real-world problems of data consistency, integrity and governance.

Such neuronos® applications as iRAW, iPQM, iTMF and iRCS represent our portfolio reaching in various phases of the life sciences life cycle.

You build up from processes and their data up to the functional services: And then combine those data driven "micro services" into more complex applications.

With this change in paradigm – away from tightly coupled applications that focus on the user interface – neuronos® exposes the underlying business functions as well connected services which can leverage complexity in nearly every process landscape in the life science industry, Drug Discovery, Non-Clinical, Clinical, Regulatory, Post-Approval.

Businesses grow and while doing so, they will create more data – data that needs to be meticulously managed, monitored and utilized properly.

Archiving and e-archiving is vitally important for a complete information lifecycle but also helps to fulfill regulatory requirements and process compliance.
The challenge for an e-archive is no longer just to get the required information into an actual archive – but rather keeping archived data accessible for audits and inspections, all along with necessary quality measures and applicable corrective and preventive actions.
iARQ is ready for end-to-end data integrity and uncompromising inspection readiness at any stage of the life sciences lifecycle.

neuronos® comes with a scalable, modular architecture, with an emphasis on GxP compliance and native raw-data capabilities. This enables modern enterprises to leverage their growing assets within and across the borders of their organization. biomedion’s truly metadata-driven platform neuronos® is capable of handling the future.

neuronos® leverages a universal access to all your data, with next-generation data transfers, collaboration capabilities and governance.

With neuronos® you can easily go the extra mile in data governance and become a truly compliant data organization.

Computer System Validation

We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits.

HIGHLIGHTS

Validation Plan
Risk Analysis
Traceability Matrix
Test Plans
Test Protocols
Test Reports
Much more!

Discover our Validation Services

Regulatory Operations Services

The team at biomedion has extensive and diverse submission experience and is ready to assist with your specific needs. We specialize in the planning, processing and submission of original and lifecycle submissions to Health Authorities. We are submission and eCTD subject matter experts and offer flexible and efficient support for all stages of a regulatory application.

HIGHLIGHTS