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
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
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.
2017 has been rife with activity in the Life Sciences sphere. But now, 2018 has begun, and, as would be customary, it is time to move on from the past, and to look forward to what this next year will bring. 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.
As life sciences companies face enormous challenges to comply to the increasingly complex regulatory environment and more and more of the world adopts the fully electronic eCTD submission format, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will it impact both the sponsors and health authorities alike? Read more
A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for:
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.