Posts

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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