Risk management is a process used to identify the risks involved in the activities that a business undertakes, or fails to undertake, as it tries to achieve its commercial objectives. Risk management also involves a coordinated effort to minimize and control these risks. Compliance is a related concept - it is an attempt to apply standards set down by someone else, such as a regulatory agency. Non-compliance is itself a type of risk.
It is true that risk is unavoidable. However, when it is understood and quantified it can be managed, giving a business an advantage against less well-prepared rivals, while helping avoid the penalties that come with falling foul of regulators and the courts.
At AstraCrux we can help pharmaceutical & biotech companies, as well as clinical research organizations, come to grips with some of the main issues involved in risk management and compliance.
Engage subject-matter experts worldwide to provide the most uptodate advice regarding compliance obligations and risk management strategies
Draft the necessary documentation and operating procedures to guide in implementation of the recommended strategies
Help as project managers in implementing the recommended strategies so that our clients remain compliant with the relevant regulations and laws and ensure that risk exposure is within acceptable levels
Review existing documents and agreements that our clients have in place to ensure that these are consistent with the recommended strategies
Risk management and compliance are critical areas that cannot be overlooked by any entity wishing to be successful in the modern business environment. We recommend the following resources from external sites for anyone wishing to deepen their understanding of this important area:
Four Risks Pharma Companies Face (Pharmaceutical Compliance Monitor)
Are You Prepared for GDPR? (Risk Management Monitor)
Legal Risk Management: An Introduction (Youtube)
For more information please contact: firstname.lastname@example.org