7 Elements creates custom commercial compliance tools that are tailored to fit your company’s specific business needs

We at 7 Elements are all former industry insiders who are well-versed in the complexities of today’s compliance landscape established by the Department of Justice (DOJ). The DOJ allows manufacturers to design a compliance program that matches their level of risk.

We focus on the development of practical policies, procedures, and manuals that are fit for purpose for the stage of your organization. We work together with you to create a liveable commercial compliance program to help you meet your corporate goals.

Our consultancy employs the DOJ’s 7 elements of an effective compliance plan to assess your risk and create an appropriate program.

The 7 fundamental elements to guide the design of an effective pharmaceutical compliance program:

Regardless of clinical phase, any company that interacts with providers, consumers, or payers must assess whether they need policies such as:

  • Business Code of Conduct
  • Interactions with Healthcare Providers
  • Fair Market Value
  • Advisory Board Justification
  • Pricing Committee Charter
  • Legal, Medical, and Regulatory Review
  • Clinical Liaison Interaction Trial Sites
  • Named Patient Program

These are just a few of the policies that 7 Elements can help you assess and create

7 Elements is here to guide you through today’s complex compliance challenges

After 7 Elements has established your risk profile, we will diligently work with your company to plan for items such as ethical interactions with healthcare professionals, consumers, and payers; transparency requirements; medical-commercial interactions; market access activities; state regulations; government price reporting; credentialing; and product promotion development. Manufacturers will have the option of selecting and customizing standard operating procedures, policies, and manuals—all of which will ensure your company meets all pertinent compliance standards.

7 Elements is uniquely acquainted with the complexities of anti-kickback statutes, preapproval information exchange, corporate compliance, and ethics. And because each pharmaceutical company’s business is exclusive—and healthcare regulations are constantly changing and subject to interpretation—your company’s decision to invest in corporate compliance training is a priority. When all stated objectives have been met, your company will be well positioned to protect your patients, providers, employees, investors, and shareholders.

The integration of sustainability objectives into a company’s core business strategy might be challenging, but the end product will be very rewarding and provide a structure that is indestructible. It’s also the right thing to do. Companies that integrate sustainability objectives will win the trust of regulatory agencies and other stakeholders, including advocacy groups. That means they become your partners, and then you are on the path to long-term success. 7 Elements is committed to helping manufacturers outline their sustainability goals and establishing programs to ensures success.

The Office of Inspector General states that a compliance program must begin with a formal commitment by the pharmaceutical manufacturer’s board of directors or other governing body, and developing a code of business conduct and ethics solidifies that commitment. The manufacturer’s compliance team maintains and implements relevant policies and procedures based on periodic assessments of risks rooted in the specific business and the ever-evolving compliance, regulatory, and legal environments. From time to time, manufacturers might need assistance ensuring that an audit of risks is conducted and provided to the board of directors for its review. 7 Elements is here to not only guide you through developing your code of conduct, but also to perform the enterprise risk audit required by the board.

ESG includes ethical, sustainable, and corporate governance issues, e.g., climate impact, diversity, equity, and inclusion accountability and governance, and it drives shared values. It’s a vital subset of nonfinancial performance indicators.

In 2021, the Securities and Exchange Commission (SEC) formed the Climate and ESG Task Force within the Division of Enforcement to proactively identify ESG-related misconduct. The task force had two cases in ’21 and six cases in ’22. 7 Elements expects enforcement actions to rise in ’23. To adhere to ESG practices and principles and accurately portray public disclosures, do what you say and say what you do. The SEC cracks down on misstatements. Companies and advisers take care to not make ESG-related statements that cannot be proven, whether in SEC-required filings or voluntary statements made, for example, in corporate sustainability reports, on websites, or in marketing materials. As with the governance of disclosures, ESG statements should be accurate, consistent, and verifiable . 7 Elements can assist with this process.


Our expert staff, led by a former Chief Compliance Officer and General Counsel of multiple pharmaceutical companies, can be your sounding board and an extension of your team. Don’t wait to set your company up for long-term legal and financial success. We know what it takes to protect your company and financial future. Get in touch today.

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