Image by Markus Winkler

Information Management Services

​Organizing and managing information is crucial to the success of the organization. We can help standardize and define the management of information in your systems which ultimately results in better business operations and smooth agency inspections. If you are still managing information in the file room and in the cabinets, we can help convert and categorize information so it's much more secured and accessible for your organization.​

Our Information Management Capabilities Includes:​

  • Data stewardship of data related to lists of values including data quality in RIM systems.

  • Collecting, categorizing, and managing Agency interactions in a document repository system.

  • Organizing records such as Regulatory Objectives, Commitments, Health Authority Question/Answers, email Correspondences, Approval Letters, eCTD, and Non-eCTD Submissions.

  • Converting and categorizing legacy Regulatory and Clinical records such as INDs, BLAs, NDA, ANDA, DMF, CTAs, CRFs in validated or non-validated systems.

  • Migrating data from one system to another including consolidating and identifying duplicate information.

Our Paper Record Conversion Process​​

We can assist you with all your digital conversion needs using proven industry techniques and company-specific data knowledge.

 

Our Digital Record to Submission Dispatch Process​​

We can further assist with making a digital record submission-ready and compiling submission so it can be submitted to a health authority.

 

 

 

 

 

Benefits of Converting Paper-based Records

  • Increases response times to all Agency requests with better data.

  • Employee quickly accesses digital information from multiple locations.

  • Eliminates special fireproof file rooms and costs associated with the maintenance.

  • Improves real estate utilization by eliminating paper in storage areas and/or file cabinets.

  • Ensures the original data stays secured while employees are using the digital copies for business or agency inspections purposes

Method-1.png
submission-ready-pdf.png
logo_edited.png