Benefits

  • Compliant with all regulatory activities
  • Complete overview of drug regulatory actitvities
  • Integrated work-flow engine
  • Advanced reporting feature to support information flow
  • Simultaneous accessibility
  • Reduced costs
  • Time efficiency

DRAmanager

Planning and tracking of drug regulatory activities

DRAmanager ensures the fast and smooth functioning of creating and maintaining product and device information and associated activities in accordance with the pharmaceutical, medical and health-related government and regulatory bodies around the world.

DRAmanager is a standardized and open software solution for the management of pharmaceutical product information, medicinal product information, medical device information and associated regulatory tasks. It is designed to provide you with a common overview of every aspect of your projects. An integrated workflow engine alerts you about deadlines and open tasks, which you need to process. DRAmanager accurately and efficiently keeps registered products compliant from a submission, labelling, and drug safety perspective.

DRAmanager screenshot

Total control for you and your team

Once a product/device has been created within DRAmanager, you can easily control the product/device-specific life cycle and all associated regulatory activities at the specific markets, process agency-specific questions, deficiency and approval and efficiently maintain open tasks as well as efficiently manage all processes and deadlines within the scope of the product/device.

Through its reporting features, DRAmanager supports you by sharing all up-to-date relevant information such as regulatory status, deadlines, and the approved production-related packaging or quality requirements with your team . By its design as a client/server architecture multiple users can access simultaneously to edit and process files at different sites and to import files on a central site via a corporate network.

Functional overview

Important features include the following:

  • Lifecycle management of products/devices with associated registration activities and status information
  • Support of all registration procedures including EU (MRP, DCP, NP and CP)
  • Automated task processing and integrated workflow management component
  • Parallel work is supported, in-house and internationally
  • Intuitive user interface with an improved learning curve
  • Advanced features for the creation, reuse, tracking, and printing of product/device information
  • Detailed audit trail

DRAmanager can map the company’s portfolio of products/devices in the repository with their all associated data (product specific information, device specific information, country specific information for both, for example,  package information and storage condition for an assigned country).

The system is also supported by MedDRA database for the selection of, for example, the appropriate indications and side effects. This data collection can be reused for any country-specific market presentation by adding relevant information about the actions done in those regions.

All the submitted documents and answers for the questions and reactions from the health authority can be tracked and maintained.

DRAmanager can be easily integrated into document management systems such as:

  • Ainea™
  • CSC FirstDoc™, CSC FirstPoint™
  • EMC Documentum™
  • IBM SCORE™
  • MasterControl™
  • Microsoft SharePoint 2007 and 2010™
  • NextDocs™
  • OpenText™
  • Optimal Systems™
  • QUMAS DocCompliance™

and others to share data sources or link to certain content objects.

All trademarks, trade names and service marks are the properties of their respective owners.

Available Modules

DMSconnect

Integration with leading document management systems

Customer Quote

“Our decision for the EXTEDO DRAmanager was based on its intuitive user interface, complete set of capabilities, as well as its wide range of customization possibilities. We appreciate EXTEDO’s focus on maintaining compatibility with the ever increasing amount of electronic standards and processes present in regulatory affairs, such as eCTD, pharmacovigilance and labelling.”

Michael Schaub, Business Development Director of ASPHALION