Posts

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.

Read more

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