Regulatory Information Management

Our experts combine their experience with the tools used in regulatory operations, with their knowledge of health authorities’ requirements, and with broad understanding of business processes to help clients achieve compliance with the Identification of Medicinal Products (IDMP) and to better manage their regulatory information.

Services:

  • Electronic-document-management/regulatory-information-management (EDM/RIM) data entry and document uploads (1) by conducting regular data entry, (2) by achieving backlog resolution, and (3) by acquiring complete collection of documents and data from affiliates and local agents
  • eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) data entry to the EudraVigilance Web interface (EVWEB) or through a regulatory information management system (RIMS)
  • Business administration and data stewardship for client systems by managing data stewardship in substance, product, organization, and referentials (SPOR), acting on behalf of clients or in support of clients to manage SPOR master data internally
  • Data quality by performing quality checks and gap analyses to compare multiple sources of information either internally (RIMS, regulated documents) or externally (such as the xEVMPD) so as to define recommendations that would improve and monitor data quality
  • IDMP/SPOR readiness by performing gap analyses between current sources of data within a company (Module 3; summary of product characteristics (SmPC); RIMS, as well as other systems) and IDMP and SPOR requirements
  • Implementation of IDMP/SPOR for two of the four domains of master data (organizations and referentials) in systems: Performance of gap analysis and development of recommendations for alignment and cleansing activities
  • Data governance by defining the single source of truth within a company, by learning about the company’s data ownership management, and by building a master-data-management approach
  • Interfaces between RIMSs and other systems by designing and implementing a RIMS and other systems in manufacturing, supply, or drug safety

System and Change Management in Support of Companies to Integrate New, Datacentric Approaches

Our consultants and experts are skilled in project management and have deep knowledge of business processes for the support of both system change and change management.

Services:

  • Implementation of new or upgraded regulatory-information-management (RIM)-related systems such as electronic document management systems (EDMSs), RIMSs, publishing, labeling, promotional materials, quality systems)
    • Project management on the business side
    • Change management
    • Process modeling and procedures as well as writing and maintaining work instructions
  • Design and configuration, migration, and reports and dashboards
    • RIM end-to-end oversight
    • Support for creation of road map—from current state to end-to-end vision
    • Design and creation of business cases for new systems implementation

28 years

of offering consulting services as well as managing the outsourcing and insourcing of projects