• Datum
    29. March 2023
    We analyze and evaluate the regulatory requirements for registering a medical device software as a German digital health application (DiGA) using the fast track approach established by the BfArM. This includes performing an MDD-to-MDR gap analysis on technical documentation and determining binding delivery conditions that take into account important factors such as data protection, information security, clinical safety, functionality, and quality. This will help gain a competitive advantage in accessing the medical market.
  • Datum
    16. February 2023
    The biocidal applicability and hereafter requirements as well as costs and timelines for the registration of an innovative antimicrobial biocidal product are investigated, the registration options are evaluated and visualized into a clear basis for decision-making regarding further use and distribution in the EU and Switzerland for the management. In addition to the project management, we are responsible for evaluating the active ingredient identity and clarifying the regulatory status, summarizing the national registration requirements in Switzerland and the EU, and developing strategic recommendations for action.
  • Datum
    30. November 2022
    The regulatory-critical database of a pharmaceutical company is migrated from Oracle 11 to MSSQL, tested and validated according to GAMP5. By introducing efficient project structures, the deadline of only two months can be met without interrupting business processes.
  • Datum
    30. November 2022
    Automation of regulatory affairs business processes through the introduction of rule-based workflows. The implementation and validation of a digital platform solution (SaaS) enhances the management of electronic submissions and regulatory documents. This streamlines the compilation, publication, approval and management of regulatory activities in the lifecycle of pharmaceutical products. With this approach we enable and ensure that legacy systems are replaced, and data is migrated correctly and completely in a timely manner to maintain GxP compliance.
  • Datum
    30. November 2022
    Successfully updated and validated a pharmaceutical company's regulatory critical application within a tight timeframe. Established efficient structures, closely tracked all activities, and quickly resolved challenges to ensure compliance without prolonged business process disruptions.
  • Datum
    11. October 2021
    Introduction of an end-to-end Regulatory Information Management in the cloud (LifeSphere RIMS), migration of data via 5 interfaces as well as definition and training of associated processes with the goal of creating a source that unifies all data and creates a complete overview of the status of all documentation. More efficient structures and solving the challenges of previous applications provide a higher quality in data management. Efficient project planning with a test matrix to track all ongoing activities and a total of 875+ test steps ensured that resources were used sparingly.
  • Datum
    17. April 2020
    The introduction of the Veeva Vault solution creates a digital, harmonized, and agile end-to-end manufacturing process that can be seamlessly integrated into the existing system landscape. This simplifies processes on a global scale and reduces operating costs by 20%.
  • Datum
    17. February 2020
    The introduction and global rollout of a customized, cloud-based portfolio management system for all GxP-relevant applications improves data quality and thus decision-making. Approval workflows ensure that the validated status is maintained.