Posts

Ede Faludi - CEO DACHS with Geert van Peteghem - CEO DocShifter

DocShifter and DACHS Partner Up to Help Life Sciences Companies Deal With the Growing Challenges Around Advanced Document Conversion

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

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

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

TOPRA 2018

Network with us at the TOPRA healthcare regulatory affairs conference 2018

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.

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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.

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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

eCTD Triangle and Modules

A closer look into the eCTD triangle and its modules

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.

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