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Biotechs: should you bring your regulatory work in-house?

Andy Haywood our consultant managing the role
Andy Haywood our consultant managing the role
Posted: 29/10/2019

Outsourcing regulatory affairs work is common among small to medium biotechnology companies, but it’s often for want of a better option. The majority of these businesses are forced down the outsourcing route – even when it does not deliver the desired results or cost-effectiveness – because they struggle to find the right RA candidates to bring in-house.

Due to their complexity, RA roles requiring experience with biological products are not fully understood by many recruiters. Indeed, this is a fault we recognised in ourselves a few years ago – and the discovery led to the establishment of our Biotech Team.

Having developed specialist knowledge of the biotech arena – and an extensive network of regulatory professionals working on large molecule products – our consultants are now helping biotechs across the UK to recruit in-house.

So, given the option, should you move your regulatory work in-house? Unfortunately, there’s no easy, one-size-fits-all answer. The best solution depends on your company’s size, location, product portfolio and core strengths, as well as the extent and expertise of the support you require. To help you discover the best solution, we’ve explored some of the pros and cons below.

Outsourcing

The benefits of outsourcing regulatory work can include access to a variety of expertise, flexible costs and increased internal focus on your business’ core strengths.

However, it’s important to weigh up the benefits of outsourcing against the associated costs and risks. In the regulatory environment, the potential issues and complications of outsourcing can include:

  • In house staff allows us to control our budget and monitor priorities continuouslyData security
  • System access
  • Managing third party performance
  • Changes in staff within the outsourcing company
  • Loss of control
  • Increased compliance risk
  • Impact on internal employees, internal change management
  • Disputes / confusion around shared internal responsibility
  • Internal process codification
  • Unsustainable savings, renegotiating contracts

In-house

Hiring in-house regulatory professionals is not always a feasible solution, particularly for early-stage businesses and those with inconstant regulatory work. Yet many businesses realise significant benefit from bringing their regulatory support in-house:

  • Full control and oversight
  • Greater influence over performance, prioritisation and time-management
  • Dedicated support (unlike an outsourced supplier, which will have other clients)
  • No extra charges if a project runs for longer than expected
  • You know exactly who’s doing your work and who you’re paying for (unlike with an outsourced supplier, who may use senior staff to win the contract but put junior staff on your account team)
  • Employees tend to have greater commitment to your organisation’s objectives
  • Better interdepartmental communication, due to proximity and shared company culture
  • In-house support is an investment that will help future-proof

Case study: Why ReNeuron keeps their regulatory work in-house

Our client, ReNeuron, is a leading, clinical-stage stem cell business based in Wales. Below, the company’s Head of Regulatory Affairs explains why he chooses to hire regulatory professionals in-house, rather than outsourcing the team’s work.

“As a small biotech company working in the stem cell space, outsourcing of certain activities can make good business sense. However, as we grapple with the complexities of our development programmes, the close interactions required between functions on a day-to-day basis means that on-site staff play a key role in achieving our objectives.

A mix of permanent and contract staff give us their dedicated support; they develop a sense of ownership and collegiate working, which is essential to our progress. In-house staff allow us to control our budget and monitor priorities and objectives continuously. They have greater involvement and a less task-orientated approach than in an outsourced context, allowing us to benefit from new ideas, insights and ways of working.”

Shaun Stapleton, ReNeuron

If you’re still not sure, or want to explore your options further, why not get in touch with one of our regulatory professionals.

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