Compliance Risk & Needs Assessment for Life Sciences Companies
The life sciences and healthcare industry continually faces challenges arising from new and evolving regulatory guidelines, laws, and enforcement actions. As a result, routine activities and tactical decisions have become areas of heightened risk, challenging companies’ ability to instil and sustain a strong culture of compliance across their organisations.
These risks originate from multiple directions and affect a wide range of internal functions, including sales, marketing, medical affairs, research and development, operations, and finance. Navigating this complex environment can be challenging, making it difficult to assess where your organisation sits on the risk spectrum.
Baker Tilly’s life sciences and healthcare advisory and support team delivers proven risk assessment methodologies that provide a comprehensive view of the current state of specific risk areas within an organisation. Risk profiles vary by company size, sector, complexity, and geography; therefore, Baker Tilly customises its approach to suit each client’s unique needs, ensuring that all key risks are identified and that remediation efforts are appropriately prioritised.
Risk Assessment
The first step is to evaluate each risk area across the organisation to develop a clear understanding of the company’s overall risk profile. To be effective, assessments must employ a standardised, consistent, and comprehensive methodology that incorporates defined risk parameters and ratings.
Compliance assessments must also consider all relevant local and regional industry codes and regulations affecting our clients. Accordingly, our life sciences team is well‑versed in the APAC regulatory environment, including areas such as Anti‑Bribery and Anti‑Corruption, Conflict of Interest, Healthcare Professional Engagement, and Third‑Party Interactions.
Beyond core risk evaluation, we believe it is essential to focus on the operational realities of effective risk mitigation. As such, we complement our assessments with practical implementation plans that address operational processes, resourcing, training, and automation requirements—enabling our clients to translate insights into sustainable compliance outcomes.
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.
