Why Businesses Are Outsourcing Regulatory AffairsIn the past 12 months we have engaged with more businesses than ever before who are seeking to outsource part or all of their regulatory function. Their reasons for doing this are manifold. In some cases they have chosen to do so because they have struggled to recruit suitably qualified staff for their regulatory affairs departments. Qualified staff in the sector are hard to find and companies struggle to hold on to highly sought after staff. Furthermore, some companies that are based outside of the large urban areas (as many SME manufacturers are) struggle to attract and retain staff in their more ‘remote’ areas. Both of these challenges (attracting and retaining staff) can have a detrimental impact on a business. The inability to operate a regulatory affairs department satisfactorily because of HR related issues can have a knock-on effect to the commercial aspect of the business.
Speeding Up The Regulatory ProcessMany other companies,those not constrained by talent availability, have chosen to outsource in an effort to speed up the regulatory process and to better enable them to get their products on to a market and to keep them there. Again, commercial considerations are playing a role in driving more companies towards outsourcing.
Three Types of OutsourcingThe three areas of regulatory affairs outsourcing that we most frequently see are:
- Tactical Outsourcing
- Low-risk Outsourcing
- Strategic Outsourcing