When we work with companies to develop organizational structures and operational Regulatory Affairs, industry leaders regularly tell us they would not have organized their function as it is today.
The following are some of the reasons why they had evolved in such a way:
Small to medium enterprises (SMEs) traditionally use staff augmentation to plug gaps in expertise
Rushing to get a company’s first asset to market
Smaller companies transforming from R&D to commercially-driven enterprises
Larger companies growing through M&A
Large corporates leaving Regulatory Affairs out of wider structural changes
The situations we encounter vary, so each one must be examined on its own merits and with high levels of domain expertise to be able to understand its nuances quickly. The reasons why Regulatory Affairs departments have remained untouched and poorly served by transformation are because they are often not understood by their organization, let alone external generic management consultants.
There may also be specific issues that you would like to attend to in your function. We take the approach of looking at the causes of the issues through triangulated analytical methods to ensure evidence-based conclusions are delivered.
The benefit of working with G&L is that rapid assessments can be delivered with meaningful insight and benchmarked against our research and knowledge of the Regulatory Affairs industry.
The output of the analysis is a road map to deliver change with specific milestones and objectives. It is important to see tangible and measurable changes delivered against expectations and a demonstrable return on investment.
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