Vulnerability Assessments, Compliance Audits & Due Diligence

Exponent’s scientific and regulatory consultants can conduct vulnerability assessments of regulatory and safety systems, perform compliance audits, and carry out due diligence projects. Often working with clients’ in-house counsel or outside law firms, Exponent provides the technical and regulatory capabilities needed for time-sensitive and issue-sensitive work that is critical for business success.

Vulnerability assessments consist of reviewing the systems that companies have in place, to ensure compliance with regulatory and safety requirements. The goal of such projects is to identify weaknesses in the system that may lead to compliance issues or products that do not meet safety specifications. Exponent works to determine areas that need improvement, and to recommend measures to resolve problems. Such systems assessments often lead to new or revised standard operating procedures and policies. Exponent then works with client personnel to implement needed system changes, including training and internal communications approaches to ensure that company staff understand the need for system upgrades.

Exponent also conducts compliance audits that are designed to review company systems and records, with the objective of identifying cases of non-compliance. Audits of this type are generally performed under the oversight of legal counsel and are conducted in response to compliance problems identified by regulators or company personnel. Follow-up audits may be initiated to determine the magnitude of compliance problems, and to mitigate possible enforcement penalties by taking action to address the causes of compliance issues. 

Due diligence projects focus on system and records reviews to identify and evaluate possible regulatory problems that affect the value of companies and their products. Because of the expertise and experience of Exponent staff, due diligence work often includes not only a review of the current regulatory status of company products, but also an analysis of the anticipated regulatory status of products in the future, on a global basis. Often, such initiatives must be conducted within short time frames. The results of Exponent’s due diligence projects provide critical information for our client’s use in determining next steps in merger and acquisition initiatives.