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Who We Are

Integrity & Compliance

At Kaléo, we are dedicated to creating innovative healthcare solutions to meet the growing unmet needs of patients.

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This responsibility requires that patients, caregivers and clinicians have trust in Kaléo. We recognize that good intentions and hiring good people is not enough. Building and maintaining trust is a daily practice for all Kaléo employees.

Appropriately, the pharmaceutical industry is highly regulated by the United States and other governments. Regulating industries that have the ability to directly impact patients’ lives is necessary. We respect those who seek to protect patients and improve patient outcomes.

Government regulations inform the development, manufacturing, and commercialization of Kaléo products. There are also regulations that inform how we support our products and conduct ongoing safety monitoring. Complying with laws and regulations is the minimal expectation for Kaléo employees. To be a trusted company, we commit to demonstrating integrity, the foundation of The Kaléo Way, in all that we do.

To meet these expectations, Kaléo has implemented an Integrity & Compliance Program (“The Program”). The Program consists of key elements that Inform, Support, Monitor and Enhance compliance with Kaléo and external requirements.

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Kaléo’s Integrity & Compliance Program

The primary focus of the Integrity & Compliance Program is on daily interactions with the Healthcare Community. The Program described below works jointly with Kaléo’s Quality Program, which provides similar support for the development and manufacturing of Kaléo’s products.

INFORM

The Program informs compliance through the development of policies, procedures, and work instructions. The principles in our policies inform what our standard is on a given requirement. The principles are intentionally connected to The Kaléo Way and how leadership believes we can best demonstrate our integrity. The procedures and work instructions inform how we can appropriately and effectively implement the requirements. We leverage various training approaches (e.g., computer-based training, live group events) that embrace adult learning principles to further inform what is required and how we most effectively implement. 

SUPPORT

The Program support begins with each employee at Kaléo. Compliance is not owned by a department but is a commitment made by each employee. As a result, our leadership must provide valuable coaching, evaluation and support in meeting the Kaléo requirements. The Program provides valuable leadership training and tools to support their efforts. Our leaders create an environment that helps their teams be successful, including being compliant with Kaléo requirements. They offer support and hold each employee accountable to being their best self, which includes demonstrating integrity. 

MONITOR

Policies inform staff of key requirements. Processes are intended to maximize efficiencies and ensure compliance with numerous requirements. Monitoring of key requirements and process compliance occurs in two ways. First, the business monitors numerous processes they own or engage. In addition, independent monitoring is performed by teams outside of the processes. The Integrity & Compliance team consolidates and assesses monitoring efforts. Using advanced data analytics, the results are shared on a quarterly dashboard, providing leaders with actionable data to improve performance. 

ENHANCE

There are numerous feedback loops that inform ongoing enhancements to The Program. In addition to monitoring activities, local leadership teams and the Compliance Committee can inform improvements. Investigations into alleged non-compliance include a root cause analysis that may inform improvements in process and training. The Program staff also commit to developing their professional skills, which includes benchmarking best practices. Lastly, The Program conducts listening sessions of various employee groups to inform program improvements. 

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Resources & Disclosures

Feedback & Concerns

We are hopeful that we have created an expectation for how Kaléo will operate ethically. At Kaléo, we strive to be our best selves every day and whatever we do, to do well. If ever you observe any member of the Kaléo team, or our partners, fall short of your expectations, please contact us.

Contact the Integrity & Compliance Team Directly

 

Employees, members of the healthcare community and others are encouraged to contact Kaléo’s Integrity & Compliance team directly with any questions or concerns related to Kaléo, its parents, affiliates or subsidiaries.

Please contact us at compliance@kaleo.com.

If preferred, a member of the team will also speak live to address feedback and concerns. Please email the above address to arrange a time to speak live.

 

compliance@kaleo.com

Contact the Kaléo Helpline

 

The Kaléo Helpline is always available for anyone to contact the company about a concern related to Kaléo, its parents, affiliates, or subsidiaries or to get information.

You can call (877) 338-3039 or visit lighthouse-services.com/kaleopharma.

The Compliance Helpline is administered by an independent outside contractor to allow confidential and anonymous reporting. Though not required, those who contact the Helpline are encouraged to leave a name and phone number in case additional information is needed.

Kaléo Helpline
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