Life Sciences Fair

Exit Brexit? Our 5 takeaways from TOPRA 2018

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:

  1. Human medicines
  2. Medical devices
  3. 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

6 Rocking Reasons to Rethink Rendering

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

5 steps to reduce risks from your current correspondence tracking solution

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

Compliant Rendering Tool

6 good reasons why leading Life Sciences companies are rethinking their content rendering solution

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

Partner Testimonial

Strator recommends DocShifter because of attractive ROI

Our partner Strator helps companies with everything to do with documents, with a wide range of hand-picked technologies, deep business understanding and long experience. They work in any industry but Life Sciences is by far their most dominating market and experience. Read more

Legacy Refresh

What to do with Legacy Data?

Many companies sit on a big pile of old data or use outdated systems to manage certain company information. These legacy data and applications might still be valuable to the organization, but their inefficiency, poor usability and high maintenance cost do not weigh up against the benefits. To get the most out of your legacy data you should convert these files to new file formats to keep them accessible, readable and searchable in the long term. Read more

Key Disruptors Life Sciences

What are the key disruptors for Life Sciences in 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.

Read more

eCTD

What’s next after eCTD?

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

eCTD Life Sciences

Frequently asked questions on the eCTD format (Part 2)

The electronic submission requirements (CDER/CBER) will apply to the following types of submissions: Read more

eCTD Life Sciences

Frequently asked questions on the eCTD format (Part 1)

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: Read more