PDS’ new US office has European focus
The new unit, under the leadership of Jeff Rudolph, will help firms wishing to make drug products in Europe with everything from quality management and regulations to the sourcing of local contract development partners.
PDS will work with pharma industry clients to set up clinical trials in Europe, leveraging its regional knowledge and experience. The company will also help non-European firms launch products locally.
Michael Gamlen, PDS’ MD, said: "We have built up a bank of expertise in our team that can considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe.”
Gamlen went on to explain that PDS’ business from US companies has steadily increased and the new office is designed to ensure that the firm can effectively manage its expansion in North America.
US firms “surprised” at amount of EU red tape
The importance of local knowledge was emphasised by PDS’ director of regulatory affairs Janet Ellis who explained that: “It often comes as a surprise to our US clients that there are so many different requirements [in Europe].”
She explained that US firms used to complying with rules laid out by single agencies like the US Food and Drug Administration (FDA) are often unprepared for the demands of the 30 plus national regulatory bodies that operate in Europe.
Gamlen echoed this idea, explaining that: "Only the largest US pharmaceutical companies employ a dedicated team to manage their European developments in clinical trials and product introduction.
“Smaller firms have found that, by outsourcing…they are sufficiently fleet of foot in terms of regulation, quality management, European legal issues and the sourcing of high quality local contractors to be able to achieve time-to-market targets.”
