Pharmacovigilance: navigating differing requirements
in Europe and the US.
The rise & rise of biotechs.
Compared to 20–30 years ago, the pharma market’s make-up today is becoming less biased towards large pharma, with growing volumes of biotech companies emerging and thriving – often under their own steam, as in the case of Moderna.
But those that choose to boldly go it alone, rather than pursue acquisition by one of the big global pharma brands, must navigate the complex regulatory demands of their target markets.
These requirements can differ significantly by region or country, and even by product type (small molecule drug vs advanced therapeutics/biologics vs drug/device combinations).
This is particularly the case for…