Tris Pharma: Putting Patients First Through Responsible Practices

At Tris Pharma, building trust is essential. We’re dedicated to the highest ethical standards and strong compliance practices in everything we do. This commitment ensures the safety and effectiveness of our products, protects patient data responsibly, and fosters strong partnerships with healthcare professionals and the communities we serve.

Building a Culture of Compliance

A strong culture of compliance is essential to ensure we operate ethically and responsibly. Our comprehensive compliance program governs all aspects of our operations, fostering a culture of integrity and adherence to the highest standards.  Here’s how our program ensures we put patients first:

  • Ensure Product Safety and Efficacy: We adhere to strict FDA regulations throughout the development, manufacturing and marketing of our products. This commitment guarantees that our medications meet the highest quality standards and deliver the intended therapeutic benefits.
  • Protect Patient Privacy: We take data privacy very seriously. We comply with all applicable laws and regulations, such as HIPAA, to safeguard the confidentiality and security of patient information entrusted to us.
  • Maintain Ethical Interactions With Healthcare Professionals: Our interactions with healthcare professionals are guided by industry codes and our internal policies. This ensures that our communications are transparent, objective and focused on providing accurate information about our products.
  • Promote Responsible Financial Practices: We uphold the highest ethical standards in all financial transactions. We have clear policies and procedures in place to prevent fraud, bribery and other financial misconduct.

Compliance Framework

Based On The Seven Key Elements of Compliance

At Tris, our dedication to developing and maintaining thorough and well-defined policies and procedures is essential for ensuring compliance. We aim to create a clear framework that supports consistent practices and decision-making across all departments. Our guidelines are meticulously crafted to address current regulatory requirements and are flexible enough to adapt to future changes. By regularly reviewing and updating our policies, we foster an environment of clarity and accountability, which enhances our ability to navigate complex regulatory landscapes and supports the organization.

Investing in ongoing training and awareness programs is a foundation of our commitment to compliance. These programs provide employees with the knowledge and skills they need to navigate complex regulations and make ethical decisions. Our training programs are designed to be comprehensive and adaptable ranging from interactive online, live and virtual workshops, ensuring everyone can learn effectively. We empower our employees to contribute effectively to our compliance goals and maintain the highest standards of ethical behavior.

Our mission is to safeguard ethical excellence by implementing robust auditing and risk assessment processes. We foster a culture of accountability and transparency, building trust with all our stakeholders. Through proactive monitoring and assessment, we identify areas of risk or non-compliance enabling timely improvements. We utilize comprehensive auditing and targeted reviews to address issues and establish risk mitigation plans, reinforcing our commitment to upholding industry standards. This ongoing process involves regular evaluation of our adherence to established policies and procedures.

At Tris we believe collaboration is at the heart of our compliance efforts. We prioritize clear and open communication because compliance is everyone’s responsibility. By engaging in regular discussions with employees, partners and customers, we ensure a mutual understanding of compliance expectations. This open dialogue enables us to swiftly address concerns, identify potential risks collaboratively and celebrate our achievements. By leveraging the diverse perspectives of our stakeholders, we strengthen our compliance program and foster a culture of integrity and accountability.

Our mission is to empower organizational excellence by integrating strategic compliance measures with continuous improvement initiatives. We are dedicated to proactively monitoring and auditing our processes to ensure alignment with ethical standards and regulatory requirements. By leveraging data-driven insights and feedback, we identify opportunities for process enhancement and implement effective corrective actions. This proactive stance not only minimizes the risk of non-compliance but also fosters a culture of ongoing development and ethical integrity. Through collaboration and clear communication, we work together to uphold the highest standards of compliance and build a strong, transparent and accountable organizational culture.

Recognizing that a dynamic compliance program requires ongoing evaluation and enhancement, continuous improvement is central to our approach to compliance oversight. We strive to ensure that all program activities are conducted with integrity and transparency. Our Compliance Committee actively addresses potential issues, recommends corrective actions and fosters a culture where ethical behavior is paramount. By embracing a proactive approach to compliance oversight, we ensure our practices evolve with regulatory changes and industry standards. Through these efforts, we reinforce our dedication to maintaining the highest levels of trust and accountability.

Transparency in Action:

Transparency is a cornerstone of our commitment to compliance. We believe that operating openly and ethically builds trust with healthcare professionals, patients and the communities we serve. To demonstrate this commitment, we adhere to all applicable laws and regulations, ensuring the highest ethical standards, including:

  • Anti-Kickback Statute (AKS): This law prohibits offering or receiving remuneration to influence the referral of healthcare services or products.
  • False Claims Act (FCA): This law prohibits submitting false or misleading claims to government healthcare programs like Medicare and Medicaid.
  • Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) Regulations: These regulations ensure the quality, safety and efficacy of our products.
  • Data Privacy Laws: We comply with regulations like HIPAA and FTC health privacy rules to safeguard patient information.
  • Industry Codes: We follow ethical guidelines such as the PhRMA Code on Interactions with Healthcare Professionals.

 

Declaration of Compliance for California

At Tris, we are committed to the highest ethical standards in our interactions with healthcare professionals throughout California. This commitment extends to adhering to all applicable laws and regulations, including the California Health and Safety Code Sections 119400-119402 (California Compliance Law).

To ensure ongoing compliance, we’ve established a Comprehensive Compliance Program (CCP). This program reflects our commitment to ethical conduct and upholds the standards outlined in the California Compliance Law.

As of January 2024, we are in compliance with both our CCP and the California Compliance Law. We are committed to maintaining this level of compliance through ongoing monitoring and review processes. This declaration will be updated annually.

Report a Compliance Issue: Your Voice Matters!

We encourage you to report any suspected violations of our policies or the law. You can report a compliance issue anonymously using one of the following methods:

  • Ethics and Compliance Helpline: This hotline offers completely anonymous reporting. Call 844-956-3287 or report online via trispharma.ethicspoint.com.
  • Supervisor or Manager: Concerns can be discussed directly with a supervisor.
  • Human Resources Department: The HR department is available to receive reports and answer questions.
  • Compliance Officer: Reports can be submitted directly to the Compliance Officer via email at legal@trispharma.com.
  • Report ALL TRIS product complaints (PQC) or adverse drug experiences (ADE) ASAP, within 1 business day.
    • Call (732-940-0358) or email:
      • ProductComplaints@trispharma.com (PQC)
      • DrugSafety@trispharma.com (ADE)