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How Document Conversion Can Impact Regulatory Operations [Whitepaper]

In highly regulated industries, like Life Sciences, where a lot is dictated by regulatory authorities, compliance comes first. Organizations must get to market fast, as business needs are growing.  At the same time, regulatory pressure can slow down innovation.

Organizing processes in the most efficient way is key. Document conversion plays a big role here.

This whitepaper broadens the spectrum of document and PDF conversion in Life Sciences, and demonstrates that document conversion goes beyond excellent technology.

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. 

To help expedite the review and approval of new medicines, China will soon join other Asia Pacific countries in accepting submissions in a fully electronic eCTD format. The implementation of eCTD in Japan and Thailand highlighted many hurdles for both domestic and international biopharmaceutical companies, some of which can be avoided.

CFDA eCTD Adoption

After joining the ICH (International Conference on Harmonization) in June 2017, China’s draft eCTD guidance has now been provided by the CFDA (China Food & Drug Administration). It is time for any organisation looking to gain approval for their products in the Chinese market to prepare to take advantage of this regulatory change.

Introducing DocShifter, the Switzerland of Advanced Rendering

In our previous posts, we introduced our understanding of what Advanced Rendering is.

We shared why this Advanced Rendering is more than just having the right technology in place and set out 3 guiding principles on how this can be improved.

For an enterprise to get a grip on all the benefits of sharing, broad usage throughout the entire life cycle of a document and automation, various technical features must be there to make this happen. We will now focus on those technical features which a rendering system needs in order to be truly advanced.

Enter DocShifter.

 

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6 good reasons why leading Life Sciences companies are rethinking their Document 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

What’s next after eCTD?

Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, 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

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

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

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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6 unique challenges of life sciences compliance

In highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations. The complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Understanding the requirements and the regulatory standards is the key. Read more