Sales & Marketing
Life sciences sales and marketing departments face a number of challenges not present in other industries. Developing effective yet risk appropriate sales and marketing strategies in the life sciences industry is often a long and difficult process.
KLS knows that promotional material reviews must be performed flawlessly; otherwise companies run the risk of receiving some type of an enforcement letter from the FDA. Sometimes actions undertaken by the FDA may spark investigations by the Department of Justice (DOJ), often resulting in significant fines, reputational harm and/or Corporate Integrity Agreements (CIAs) that potentially impose additional processes and restrictions on companies. Our team has experience developing and implementing promotional material review structures and serving in leadership roles throughout the entire promotional review process that includes final submissions to FDA. We leverage this knowledge to help clients streamline their promotional review process and avoid regulatory action.
In addition to the challenges associated with the development of materials and strategies, sales and marketing departments face unprecedented scrutiny with respect to their interactions with healthcare professionals. Both federal and state governments are clear that sales and marketing departments must ensure that their interactions with or engagements of healthcare professionals are not used or perceived as kickbacks or any other type of improper incentive to utilize particular products. Our team relies on its own in-house experience to develop practical programs designed to ensure that sales and marketing teams operate within appropriate boundaries while meeting business objectives.