The life sciences and healthcare industry is constantly facing challenges 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 instil a culture of compliance within the organisation. 

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. 

Baker Tilly's life sciences and healthcare advisory and support team delivers proven risk assessment methodology providing a comprehensive look at the current state of specific risk areas within an organization. Risk varies by company size, sector, and complexity as well as geography; as such, Baker Tilly customises our approach to best suit each client ensuring all needs are identified and actions steps are appropriately prioritised. 

Risk Assessment 

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 utilise a standardised, consistent, and comprehensive methodology which takes into account certain risk parameters and ratings. 

The compliance assessment must also take into account all key local or regional industry codes or regulations impacting our clients. For that reason, our life sciences team is well-versed in the regulatory environment in APAC in areas such as Anti-Bribery and Anti-Corruption, Conflict of Interest, Healthcare Professional Engagement, and Third Party Interactions. 

Our team also believes it is important to move beyond the core evaluation of risk utilising our standard methodology and to focus on the operational aspects of effective risk mitigation. Thus, we complement our assessment with tactical implementation plans that focus on the operational, resourcing, training, and automation needs of our clients. 

Check out this case study on how we have helped our client, a start-up clinical-stage biotechnology company, prioritise resources in both capital and headcount, thereby allowing them to operating more efficiently in the short-term and plan for the commercialisation of the organisation.