Transformation is among the most overused and least understood expressions in modern business.
Research shows that around just 30 per cent of transformations succeed.
Within our G&L Insight Advisory Practice, we believe this is a direct result of management consultancies with little to no knowledge of the Regulatory Affairs industry applying generic solutions, shoehorned into situations regardless of the actual need or required outcome.
We work differently.
We believe a comprehensive understanding of your functional area is the only way to determine the appropriate course for change.
As seasoned Regulatory Affairs industry experts, we have the benefit of a wide range of experience in different settings and will undertake a deep analysis of your situation to determine an individual roadmap solution for your company and your business transformation projects.
Following a clear understanding of the ‘as is’ position, your strategic objectives, and your future direction, a comprehensive roadmap is developed.
The resulting ‘transformation’ may be an incremental adjustment or more disruptive change using methods appropriate for your situation.
We are not aligned to a set of technologies or solutions and, as a result, provide a bespoke service for every client we work with.
Understanding the problem and defining the roadmap to delivering change is important but the execution of the transformation is critical. Our key driver is to see companies and Regulatory Affairs functions improve. We fully commit to providing high-quality execution, governance, and communication.
We believe in our services to the extent that we support our internal teams using the skills and experience that we use for external clients. This helps us improve as an organization and each G&L employee can see the benefits of the work we carry out for our clients.
Our services include:
Assessing and implementing purpose, strategy and objectives – aligned with the corporation and to develop your function
Ground up (or ‘zero-based’) design
Future-proofing your organization – Gap and risk analysis, planning and implementation
customer experience, service design, and value-demonstration
Service delivery – quality and cost objectives
Strategic resource deployment and sourcing – what to do and what not to do
Process simplification, and excellence programs (lean, and six sigma)
To us, operational excellence means improving the day-to-day delivery of Regulatory Affairs.
The issue we often find is the high degree of detail with which individual processes are defined and yet developed independently from the value stream within which it sits. Furthermore, we often see the measured output from the Regulatory Affairs team does not correlate with the business objectives as a whole.
What does that mean?
Processes – and metrics – appear to be developed for the sake of capturing the procedures, and we estimate that 80–90% of steps offer no value to the end customer.
We also hear, all too often, that Regulatory Affairs is seen as a black box within which no one understands what is happening, a homogenous mix of unfathomable documentation and activity. The challenges of demonstrating value through an intangible service involving Regulatory Affairs processes is difficult, let alone understanding capacity, bottlenecks, and priorities.
Regulatory Affairs is sometimes seen as a black box of unfathomable activity and attempting to apply OpEx methods is seen as too difficult. We believe this is a disservice to the profession and end customers alike.
We believe challenging processes, and pinpointing indicators of customer value throughout, unlocks the potential for focusing on what is important – improving efficiency – and this highlights to stakeholders the output metrics that are relevant and meaningful.
We use a range of tools and methods appropriate to the project in hand, such as:
Operating methods and system design
Strategy and planning ‘systems’
Process mapping, critical to quality requirements, process controls
Governance, FMEA, risk mitigation
SIPOC – managing suppliers and customers
Assessment and improvement
Lean and six-sigma process excellence
Digital Transformation often requires a leap of faith and imagination, especially in organizations where older processes and legacy systems still exist and there is a need to embrace new innovative technology.
We all know of countless examples of unsuccessful (digital) transformation projects or those which have failed to realize their planned value. Zero-based design enables a fundamental rethink and taking novel approaches to legacy problems.
The process is one of removing constraints or old assumptions, opening possibilities, and designing the process with a fresh perspective. Firstly, a focus on the outcome, and spending energy on clearly defining it, is the precursor to using imagination and all available assets to deliver it.
Starting with an audacious goal, a clean sheet and an open mind is scary, hugely empowering, and motivating!
By taking a fresh approach to the age-old challenges and directing energy at the desired outcome, it is possible to leap-frog approaches that require incremental development from the point at which we are today.
Service design thinking
We know a thing or two about delivering great service to our clients and this alone, we feel, is something that corporate environments can learn from.
In addition to the know-how gained from 20+ years of execution, we use service design methodology to develop operating models or address specific issues associated with the part or all of a Regulatory Affairs function. This combination is compelling for organizations looking to develop and improve in the future.
“What is service design thinking? We see it as designing great service processes with the customers at the forefront of our thinking. Simple.”
Customer input is a prerequisite for developing a great service. Service processes often involve more than one function and the interface and handoffs between them are invariably where issues or inefficiencies arise.
Hence the need to involve the team responsible for delivering the customer experience is imperative. We advocate evaluating current experience and what it aspires to be, customer journey mapping, and value creation analysis for customers as part of the process.
We find simplicity and focus underpin this type of exercise and have a range of tools and methods to facilitate the process. With our knowledge and expertise within Regulatory Affairs, we can intelligently apply established frameworks and methods making the entire process more efficient.
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