Why regulatory consultancy makes sense

At G&L Healthcare Advisors, we are proud to support companies throughout the world at every stage of development, with unrivaled subject matter expertise and decades of experience provided by our regulatory experts.

We realize that, while this work makes an enormous difference to our clients’ output, by its very nature, it is not meant to occur in perpetuity and should always have a finite lifespan.

Our experts provide vital functions such as filling gaps in experience, sharing knowledge, and triaging shortfalls in resource. While they easily integrate with our clients’ organizations and mesh within the matrices of scientific disciplines, they are also there to foster and nurture the continuity of the project team.

These roles are functional but also transitional.

So, what happens when the client’s deliverable is completed, or a full-time equivalent is hired, and it is time for that lynchpin consultant to move on?

Of course, processes will be in place to formally transition the actual work smoothly. However, disruption can still occur within the project team – especially when it involves the regulatory lead.

For every regulatory professional, technical philosophy inevitably influences how they and their colleagues approach product development.

You may have a regulatory lead who is more commercially minded than the more commonly found ‘by the book’ type or even the proverbial ‘we’ve never done it that way before’ example.

By their approach, this lead will persuade the team to abandon the reductionist mindset and embrace a more risk-taking approach (within soundness of reason, of course).

In turn, the organization may also adapt to this style and, while enjoying successful Health Authority meetings, perpetuate a culture that embraces the attitude of ‘you won’t know unless you try’ and heralds the advent of new expectations of the regulatory function.

However, how does this have an impact if the client is going through infrastructural changes that require resource reductions and the inevitable release of consultants to preserve the full-time equivalent headcount?

How does this affect the continuity of culture when the former forerunner is no longer there, and how do you prevent a regression to the default setting and even the disintegration of positive partnerships?

The solution here is the utilization of regulatory consultants that not only share knowledge and experience but also educate stakeholders at every level of the organization.

Stakeholders can be defined at the peer level, from C-suite executives to investors and even Agency personnel such as FDA regulators. They serve as refiners of technical thinking; purposefully annoying to ensure no data gaps arise that will become detrimental to their programs.

Regulatory consultants are there to provide strategic expertise for the length of their contract term, but they should also serve as coaches who train high-performing, cross-functional technical teams whose remit is to get the product approved.

At all times and in all situations, regulatory consultancy should be viewed as a relational role that is founded on the credibility of character and displays a ‘can do’ attitude that seeks solutions. The consultant is the captain of a ship that is successfully navigating the seas of evolving regulations and counseling the organization along the drug development continuum toward commercialization.

A large part of regulatory consulting entails discerning team dynamics and appreciating the needs of each subject matter expert who sits at the table.

Sometimes the deliverable dominates and working relationships suffer because the objective gets in the way, e.g., the need to be right versus protecting team dynamics. That is where egos get bruised, constructive criticism can be misconstrued as a personal attack, and things can get even messier from there.

You may say managing team dynamics is the role of the project manager and in some ways you are correct.

But as far as it impacts a team’s ability to forge strategy and tell a story with data, that is the jurisdiction of the regulatory lead. Without their active involvement and possible intervention, team thinking, and overall culture can be very easily derailed.

Underlying all of this is the overwhelming need to preserve team continuity when the regulatory consultant leaves – the offboarding process must be taken as seriously as the onboarding.

Beyond their roles and responsibilities, it is essential that the regulatory consultant ensures minimal disruption at their time of departure and does not detrimentally impact the progress of the project.

This can manifest in several ways, including stalling the project, revisiting old issues, or rogue activity in which the team disperses.

To avoid this, there needs to be a proper introduction of the historical account of what took place during the consultant’s tenure at the time of hand-off. This includes educating the replacement on team strengths and shortcomings, preferred methods of communication, how to interface with various SMEs, and, perhaps most importantly, sharing what didn’t work as well as hoped.

There must also be a disclosure of risk tolerance and expectations assumed by the regulatory function and, with that, an honest conveyance of how regulatory is viewed by stakeholders.

In short, inform the replacement regulatory lead thoroughly and ensure they are aware of the organization’s value for the function - for example, do business partners respect regulatory input, or do they shop around for answers and even solicit input from outside experts to validate regulatory points of view?

While this may seem somewhat undermining or possibly even offensive behavior, it is perfectly normal and, quite often, validation must come from external sources.

Aside from a transition plan for the next stage of work, the regulatory consultant should also provide a project debrief to the client with insights and suggestions on how to maintain cadence on a particular project and, if applicable, where improvements can be implemented.

This provides the client with clear visibility of all potential issues and sets the next person up for success as they enter the project with full awareness.

It is not just about getting the work done, but how it gets done and, most importantly, that there is no relational wreckage in due course when attrition occurs.

Related: The route to Market: Why your Health Authority relationships matter