| This study analyzed current best practices for regulatory due diligence in the medical products industries. A survey tool was developed to probe the views of industry, and was validated using a focus group of professionals with experience in legal, regulatory and quality due diligence. The survey was completed by 58 regulatory and quality professionals who have been involved in at least one due diligence activity in the medical products area. The responses of respondents were consistent with the predictions of learning theory that emphasize the importance of two dimensions, information gathering and experience accumulation, when developing best practices in regulatory due diligence. However, substantial variability was reported in the experience level of due diligence experts who participated in the due diligence exercises of the respondents. The survey results further identified that current regulatory due diligence practices focus primarily on the performance state of the company as viewed through documentation, but often fail to probe sufficiently other aspects of the organization, including the ethical and organizational state of the company. Results suggest that due diligence audits could be improved by gathering information systematically about such elements as personnel organization, decision-making styles, key personnel to be retained, and evidence of ethical questions or misinformation. These additional elements would provide information that later will be important to going forward with an acquisition and eventually harmonizing the two organizations effectively. |
