Posts

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

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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Challenges Life Sciences Compliance

6 unique challenges of life sciences compliance

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

Compliance Solution

Why the Hi-Fidelity module is your document compliance solution

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-, ISOand FDAguidelines. 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.

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