REGULATORY

REGULATORY

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Regulatory Business Process Management

arivis started with the first ever cloud-based eDMS system designed for life sciences in 2005. We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Now arivis Clireo provides the only Azure based Clinical eTMF and ISF with full eDMS capabilities. 

And Clireo eMPM supports end-to-end Promotional Materials Management for Medical, Legal, and Regulatory review and approval. Combined with Clireo eCTD and the new Module 1 for the FDA eCTD, Clireo creates the industries only integrated Promotional Materials Management system with integrated eSubmissions capabilities.

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Submission Planning and Management

arivis started with the first ever eDMS system that integrated Business Process Management (BPM). We enhanced these tools with the addition of eCTD Regulatory Submission Management along with full Virtual Data Room capabilities. Later we introduced more regulatory submission management capabilities with support for 510k, PMA, and custom submission types. 

HIGHLIGHTS

  • Regulatory documents

  • DIA EDM Reference Model

  • Submission signposting

  • Lifecycle & workflows

  • Dynamic permissions

  • Metadata

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Inspection Management

Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).

HIGHLIGHTS

  • Scheduling enable the organizations to manage inspections

  • Mapping and tracking of observations to issues and CAPA items

  • Track progress and effectiveness of corrective measures

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Regulatory Correspondence

A timely, transparent, and effective communication between sponsors and authorities are paramount during regulatory operations in drug development and can facilitate earlier availability of safe and effective drugs to patients. At the same time, it reduces frictions with later steps in the approval process.

iRAW


intelligent raw data archiving watcher
RAW Data, GxP Lab, Controls, SEND, loT

WATCH+
ARC+

IMAGE+
BYOD+
REPORT+

As well as all other Add-ons ...

iPQM


intelligent pharma quality management
QMS, qDMS, CAPA, Image QC, Issue Management

REPORT+

SIGN+
IMAGE+
BYOD+
BRAIN+
TRAIN+

As well as all other Add-ons ...

iTMF


intelligent trial master file
DIA eTMF, CRO Migration, Longterm Archiving

SIGN+

BRAIN+
REPORT+
ARC+
TRAIN+
COMPLY+
MIGRATE+

As well as all other Add-ons ...

iRCS


intelligent regulated content services
rDMS, RIM robot, IDMP/SPOR, promo mats

COMPLY+

WATCH+
ARC+
REPORT+
BRAIN+
SIGN+
TRAIN+

As well as all other Add-ons ...

RESOURCES

CUSTOMERS

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CONTACT US

For further information please contact us, we look forward to hearing from you.

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"The only way in which to treat the elements of an exact and rigorous science is to apply to them all the rigor and exactness possible."