UK pharmaceutical companies have typically met their regulatory staffing requirements by using one or a mixture of their own employees, an outsourcing partner like PharmaLex or contractors (who may or may not be through an agency). At PharmaLex, we are recognised as pioneers in regulatory outsourcing; this is due to our reputation for providing leading strategic outsourcing solutions in regulatory affairs that draws clients towards us – it is also indicative of the market trend as many pharma companies choose to outsource their mainstay pre- and post-approval regulatory activities while refocusing internally on strategic competencies.
From April 2020, medium and large (private and third sector) pharma companies in the UK will also assume responsibility for determining whether IR35 rules apply for their engagement of contractors who use personal service companies, i.e. they will be responsible for deciding the employment status of these workers. This shift in onus may place even greater emphasis on outsourcing as a core staffing model as companies look to lower their risk. For our existing clients who may be thinking about extending their reliance on regulatory outsourcing or for new customers who would like to understand what PharmaLex can offer in terms of resources and programme governance for regulatory staffing, we will always welcome the opportunity to discuss how we could tailor our leading solutions to your particular circumstances. Interested in finding out more? Please contact us at firstname.lastname@example.org.