Every industry goes through changes over time and the Life Sciences industry is no exception. But not every change is significant. With so many buzzwords and jargon being thrown around, sometimes it’s hard to wade through the noise and get to the heart of it all.
Life Sciences organizations face many challenges when tracking all of the communication that takes place between themselves and other external organizations and health authorities that they deal with on a regular basis. An essential part of any complete Regulatory Information Management (RIM) platform is the ability to plan and track all regulatory activities that an organization needs to undertake. These activities are often initiated by a request that is sent from a health authority for more information, and it is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform. Read more
The TOPRA Annual Symposium 2018 is the only Europe-wide healthcare regulatory affairs conference with comprehensive programmes covering medical technologies, human and animal medicines – this year held in partnership with the Swedish MPA at the Quality Hotel Globe in Stockholm from 1–3 October 2018.
In the highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations across all business aspects. The myriad and complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Using an efficient quality management system helps companies to simplify ICH-, FDA- and ISO- compliance. Read more
We added a new module to our range, called the Hi-Fidelity module. This module functions as an overall regulatory compliance solution. This module allows the rendition of quality documents in compliance with ICH-, ISO– and FDA–guidelines. DocShifter takes any input format (Word, Excel, PowerPoint, PDF…) and transforms them into compliant documents. With this module it is possible to add: headers, footers, logos, bookmarks and paging to your documents.