Our specialized professionals understand the regulatory environment and industry best practices for addressing them, enabling the business to do what they want to do, the right way.
The life sciences industry is constantly being bombarded with new and evolving regulatory guidelines, laws and subsequent enforcement actions. Tactics and routine activities have become areas of extreme risk, which challenges companies’ aim to instill a culture of compliance within the organization.
These risks come from all directions and affect internal functions including sales, marketing, medical affairs, research and development, operations, finance, etc. It can be hard to make sense of it and figure out where your company stands on the risk spectrum.
The first step is to look at each risk area across the company to gain an understanding of your company’s risk profile. To be effective, the assessment must utilize a standardized, consistent and comprehensive methodology which takes into account certain risk parameters and ratings.
Effective risk assessment methodologies evaluate a company’s capabilities across five core parameters:
3. People and organization
4. System and data
5. Management reporting
By focusing on these five parameters, our clients can shine the light on areas where there may be deficiencies and expose them to risk. Applying risk ratings to each can help with prioritizing those areas of need; differentiating between areas which need to be addressed immediately vs. further down the road.
Baker Tilly’s life sciences team supports our clients in: