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iRCS

Intelligent Regulatory Content Services

What is iRCS?

Tired of using excel and shared drives? Looking for a system that’s more organized and easier to navigate?  

Then iRCS is the Document Management system for you!

 We have developed a straightforward document management structure that is easy to navigate using Filters and Searches.  This technique makes the process of finding documents a quick and painless process, anyone in your organization can find a document in little to no time. iRCS has been specifically designed for the Regulatory and Executive Level Professionals in mind.  

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What can iRCS do for you?

Our iRCS is not just a document management system but a project management tool and submission compilation organization assistant.  It allows a user to author documents through both a basic and detailed workflow.  The user than has many options in terms of life-cycling a document.  Our system provides you with an updated document management option that functions like a google search.  iRCS provides you with the feasibility of moving from document to document, section to section, and application to application.

What puts biomedion above other competitors is the ability to create submission request forms, known as a Tracking Card.  The Tracking Card allows selected users to create regulatory cards that incorporate all the required submission details as well as submission eCTD structure and document location.  The transition from regulatory author to regulatory submission creator is smooth and seamless.  Our iRCS management system is indispensable for your drug development needs. 

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Intelligent raw data archiving watcher

Processes, Documents, RAW Data, GxP Lab, Controls, SEND, IoT

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intelligent pharma quality management

QMS, qDMS, CAPA, Image QC, Issue Management​


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Intelligent trial master file

Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving

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TRAIN+
COMPLY+
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As well as other
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intelligent regulated content services

Regulatory Document Management (rDMS), promo mats​


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More services

validation

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
consulting-service

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

  • Original Applications
  • Lifecycle Applications
  • Promotional Materials Submission
  • Submission Planning
  • Templates and Formatting
Services for Regulatory Compliance
maintenance-service

Technical Consulting

We advise you on the use of our solutions, make the necessary configurations for them or develop adaptations, e.g. for the integration of other products. In doing so, we work closely with our colleagues in the computer system validation department.

HIGHLIGHTS

  • Configuration
  • Workflows
  • System integration
  • Security
  • GDPR
Our professional Solutions

Interested in working together?