Braeburn Inc. comprehensive compliance program
Braeburn Inc. ("Braeburn" or “The Company”) is committed to conducting business ethically, with integrity, and in full compliance with applicable laws, regulations, and industry guidance. To support this commitment, Braeburn has developed and implemented a Comprehensive Compliance Program ("CCP").
At its core, the CCP is a set of internal standards and controls designed to promote the prevention, detection, and correction of illegal conduct or behavior that does not align with the Braeburn Corporate Code of Conduct and Ethics. The CCP applies to all Braeburn officers, directors, employees, and relevant independent contractors. It is an integral and routine part of Braeburn’s operations, demonstrating our commitment to the highest standards of ethics and compliance. The CCP is reviewed and revised as necessary to ensure it continues to meet the evolving legal and ethical requirements of Braeburn's business operations.
key elements of Braeburn’s comprehensive compliance program
1. leadership commitment
The effectiveness of Braeburn’s CCP starts with the support and public commitment of our leadership. The Braeburn Board of Directors, the Chief Executive Officer (CEO), and other members of the Executive Leadership Team are dedicated to governing and growing Braeburn through ethical and compliant business strategies. The Compliance Officer, who reports directly to the CEO and the Board of Directors, oversees the CCP. The Compliance Officer convenes a Compliance Committee with the Executive Leadership Team on a quarterly basis and provides updates on the CCP to the Board of Directors at least annually.
2. policies and procedures
The Braeburn Corporate Code of Conduct and Ethics, along with accompanying policies and procedures, form the foundation of the CCP. These documents outline the legal and ethical standards that govern Braeburn's daily activities and operations in a clear and accessible manner. They address key activities and relationships with healthcare professionals, institutions, patients, third-party payers, independent contractors, vendors, and consultants, as well as internal operations.
3. education and training
All Braeburn employees receive education and training on the Corporate Code of Conduct and Ethics, as well as applicable policies and procedures, to ensure they perform their duties in compliance with relevant laws and regulations. At a minimum, this includes distributing the Compliance Program Overview and relevant policies to each employee, officer, director, and applicable independent contractor. Additional targeted training is provided as necessary to specific functions such as Sales, Marketing, and Medical Affairs. The Compliance Officer consults with Legal to determine the need and scope of such training.
4. reporting and investigating misconduct
Braeburn personnel are responsible for identifying and reporting possible violations of laws, regulations, the Code of Conduct and Ethics, and Company policies. Reports can be made to managers, the Compliance Officer, any member of the leadership team, or anonymously via the following methods:
- Website: whistleblowerservices.com/braeburnrx
- Phone: 866-257-6068
Braeburn is committed to fully investigating and addressing all reported compliance concerns. Confidentiality is maintained to the extent permitted by law, and retaliation against those who report concerns in good faith is strictly prohibited.
5. responding to violations
When an internal investigation confirms a violation, the Company takes timely and appropriate corrective action. This may include disciplinary measures, terminating contracts, notifying government agencies, or implementing training or systemic changes to prevent future violations.
6. monitoring compliance
The Compliance Officer prepares an annual Risk Assessment and Monitoring Plan to ensure oversight of activities deemed most risky. The Compliance Officer conducts both live and transactional monitoring on a monthly basis and reviews those findings with the Executive Leadership Team and the Board of Directors as necessary. The Board of Directors regularly evaluates whether the Compliance Officer has adequate resources to monitor compliance effectively.
7. future development and refinement
As a growing pharmaceutical company, Braeburn anticipates that the CCP will evolve to reflect the increasing complexity of our operations and address new areas of risk. Braeburn’s Executive Leadership Team periodically reevaluates the CCP and implement measures to enhance its effectiveness, ensuring that all personnel remain equipped to promote full compliance as the company grows.
For questions about the CCP, please contact info@braeburnrx.com.