Thought Leadership

Blog & Article
Infographic
Regulatory requirements for combination products vary significantly by region, and registration frequently necessitates a dual assessment approach. We can manage the intricacies of borderline products and navigate unique regulatory pathways in all major markets.
Journal Article
The electronic Common Technical Document (eCTD) is 16 years old, approved by the International Council on Harmonisation (ICH) to Step 4 in 2008. It’s old enough to drive a car in the US. It’s had some small changes over the years but is still pretty much the same as it was in the George W. Bush era. It’s had a huge impact on the speed and accuracy of regulatory submissions for pharma … but it could be better. That same year, the US Food and Drug Administration (FDA) started looking at a next-generation submission format, which would become eCTD 4.0. That standard
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