We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion & enrichment in the Life Sciences industry. The advanced content conversion capabilities of DocShifter combined with the expertise of DACHS in document management for pharmaceutical companies make a powerful strategic alliance. Read more
DocShifter proudly announces its exciting new partnership with Generis Knowledge Management Inc. to provide industry-leading rendition handling as part of their CARA toolsuite. The advanced content conversion abilities of DocShifter, together with the functionality in CARA and the resulting application will provide complete compliance functionality for regulated content management use cases, especially for Life Sciences.
Serving the world’s top Life Sciences companies
“There are various regulatory requirements that our clients face to provide content in a compliant set of formats, with the features and functionality of CARA on top”, said James Kelleher, CEO at Generis. “Our integration with DocShifter enables customers to ensure that content is managed to these requirements, with a wide range of integrations that CARA also offers to other applications specifically in the Life Sciences industry.”
Our VP of Life Sciences, Paul Ireland, was at the TOPRA 2018 Symposium in Stockholm, Sweden from October 1st – 3rd to hear and discuss the latest news and initiatives within the pharmaceutical industry together with Life Sciences regulatory professionals from Europe and around the world. Due to the wide-ranging ongoing initiatives within the regulatory space across all divisions of Life Sciences, the conference was split into multiple tracks:
- Human medicines
- Medical devices
- Veterinary medicines
From the initial introduction by Lynda Wight from TOPRA, it was clear that the topic of Brexit would have a role in many of the discussions during the three day agenda. Read more
We have been converting divergent documents into a unified format such as PDF for many years now. For many reasons.
In knowledge-driven industries, the need for standardization is often highly motivated by regulators. For example, in Life Sciences, the introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. In other industries, archiving needs have led to massive content transformation as well. Transformation to de facto standards such as PDF/A ensures that documents are secure for the long term. Read more
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
We have been converting divergent documents into a unified format such as PDF for many years now.
In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And the International Conference on Harmonization (ICH) has further solidified this drive in its recent implementation guides for Regulated Product Submissions (RPS). 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.
Thanks to more than 10 years of experience, Digital First has been recognized as the leading digital event in Belgium that connects digital leaders. As the market continues to grow, disruption arrives from all angles, and to stay ahead of the game, Digital First will take place over 2 days! Read more
In recent years, the Life Sciences industry has been moving regulatory activities from paper based processes to fully digital. During this shift, they are facing enormous challenges to comply with the increasingly complex regulatory environment as more and more of the world adopts the fully electronic eCTD submission and other fully electronic formats. Read more