In the modern market, small and nimble biotechs possess many great advantages in terms of their ability to bring new innovation to market quickly, unhindered by legacy ways of operating. Yet the smallest start-ups share the same obligations as large pharma companies when it comes to safety and pharmacovigilance, which means they are likely to face a steep learning curve. Eric Caugant and Judi Sills at Arriello outline key differences in requirements on either side of the Atlantic and provide some practical tips for biotechs looking to optimise their PV budgets.