Why More Companies Are Outsourcing Regulatory Affairs

The pharmaceutical and medical device sectors are facing unprecedented commercial pressures in every major healthcare market in the world.  Issues such as increased competition, uncertainty regarding geopolitical issues such as Brexit and the individual nation’s drug pricing strategies have sent shock waves through the industry.  Now, in order to survive and thrive there is a requirement for executives within the life sciences sector to analyse every aspect of their businesses. More companies are now outsourcing their regulatory affairs requirements.

Why Businesses Are Outsourcing Regulatory Affairs

In 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 Process

Many 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 Outsourcing

The three areas of regulatory affairs outsourcing that we most frequently see are:

  • Tactical Outsourcing
  • Low-risk Outsourcing
  • Strategic Outsourcing

Let’s look at these outsourcing types one by one.


Tactical outsourcing is often regarded as a transactional or processing issue and tasks associated with it it tend to be carried out frequently. In our experience document management is one of the most commonly outsourced elements in the regulatory department.

Low-risk Outsourcing

Routine maintenance is an important element in the commercial lifeblood of a company.  When managed effectively it can be outsourced to a third party such as Acorn Regulatory and can be done so in a cost effective way.

Strategic Outsourcing

Many companies, particularly those that are regarded as ‘virtual’ operations choose to outsource all but the commercial aspects of their business.  In doing so, they are concentrating their own resources on driving the growth of their business while working with experts in a number of particular sectors, including regulatory affairs, to manage their non-commercial functions.  In a regulatory context this can be a valuable

We are increasingly seeing the regulatory strategy piece being outsourced to us.  Companies do this for a variety of reasons.  Firstly, companies rarely have the internal depth and breadth of experience that we have at Acorn Regulatory.  Whereas a company might get sidelined by a unique issue, it is highly likely that our experienced team has dealt with that issue or something similar through the course of their work with our clients.  Allowing an in-house team to get mired in a once off issue will have a knock-on effect and will, inevitably, delay matters and be an issue of concern to the commercial elements of the business.  We have developed this expertise as a result of many years of handling hundreds of projects each year.  That is why more and more companies are coming to us and seeking our input into developing their regulatory strategy.  Doing so, has enabled them to better compete in the competitive life sciences markets that they operate within.

Overall, every company has a different approach to outsourcing.  For some it is an intrinsic part of how their business is managed.  For others it is something that they are slowly integrating in to their operation.  Nevertheless, with the ‘always-on’ communications systems that are now in place it has never been easier to outsource your regulatory requirements to a third party such as Acorn Regulatory.

We encounter numerous requests for outsourcing.  In 2019 we also looked at the issues of outsourcing eCTD  and outsourcing for MAH’s.  You can read both articles by clicking the links.

If you would like to talk to us about outsourcing your regulatory requirements then call us today on 00353 52 61 76706 or complete your details below and we will get back to you.