Our Former Federal Agents Bring Centuries of Experience to Helping Companies Establish and Maintain Regulatory Compliance
Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Regulatory compliance presents challenges for all types of companies. While many federal regulations impose differing requirements based on a company’s size or financial resources, even this proportional approach leaves many businesses struggling to understand and meet their obligations.
The first challenge many companies face is simply knowing where to look. The federal regulatory landscape is extraordinarily broad, and companies can owe obligations to agencies ranging from the U.S. Food and Drug Administration (FDA) to the U.S. Department of Homeland Security (DHS). While some regulatory requirements are industry-specific, others apply regardless of the businesses or consumers a company serves.
Former Federal Agents with Deep Regulatory Knowledge and Insights
At Corporate Investigation Consulting, we provide regulatory compliance support backed by centuries of relevant experience. As former federal agents, our consultants have experience not only advising companies in the private sector, but also scrutinizing companies’ compliance efforts and enforcing their compliance obligations on behalf of the federal government. Our consultants have prior experience with federal agencies including:
- Federal Bureau of Investigation (FBI)
- Internal Revenue Service (IRS)
- Medicaid Fraud Control Unit (MFCU)
- U.S. Department of Defense (DOD)
- U.S. Department of Health and Human Services (DHHS)
- U.S. Department of Justice (DOJ)
- U.S. Drug Enforcement Administration (DEA)
- U.S. Postal Inspection Service (USPIS)
- U.S. Secret Service
Our consultants have also worked alongside agents at the Federal Trade Commission (FTC), U.S. Securities and Exchange Commission (SEC), and other agencies. With a well-rounded and deep body of regulatory knowledge, our consultants are able to help our clients meet their obligations without taking steps that are unnecessary, and we are able to help our clients thoroughly document their regulatory compliance efforts so that they can withstand federal scrutiny when necessary.
Areas of Regulatory Compliance
We assist our clients with all areas of federal regulatory compliance. Some representative areas of our practice include:
Banking and Finance
We assist banks, financial institutions, mortgage companies, and other lenders with all aspects of banking and financing compliance. This includes compliance with the rules and regulations enforced by the Federal Deposit Insurance Corporation (FDIC), Consumer Finance Protection Bureau (CFPB), Federal Financial Institutions Examination Council (FFIEC), U.S. Department of the Treasury, and other federal authorities.
Consumer Protection
Consumer protection regulatory compliance is a concern for all companies that design, manufacture, and sell consumer products and services. The CFPB, FTC, and several other federal agencies have adopted and enforce regulations that govern everything from consumer lending and collection practices to the marketing and labeling of retail goods.
Cybersecurity and Information Privacy
Cybersecurity and information privacy are critical concerns for companies in many industries—and these concerns are only continuing to grow. Not only do companies risk facing civil lawsuits if they fail to adequately protect their customers’ and employees’ data, but failure to maintain adequate cybersecurity programs could lead to regulatory enforcement action as well.
Employment
Companies have extensive regulatory compliance obligations in the employment arena. Regulations promulgated by the Equal Employment Opportunity Commission (EEOC) and other authorities add significant complexity to the challenges of complying with federal discrimination, wage and hour, and labor laws. We help companies implement policies and procedures designed to prevent prohibited employment practices and respect employees’ legal rights.
Environmental
Environmental compliance has long been an area of concern in many industries; and, with growing awareness of the causes and risks of climate change, environmental compliance has taken center stage in recent years. We help companies comply with the Environmental Protection Agency (EPA) regulations promulgated under the Clean Air Act, Clean Water Act, Toxic Substances Control Act (TSCA), and other federal environmental laws.
Food, Drugs, and Cosmetics
The FDA has promulgated extensive regulations under the Food, Drug, and Cosmetic Act. These regulations address matters ranging from clinical testing and alternate paths to FDA approval to drug labeling and warning requirements for tobacco, e-cigarettes, and other consumer products. We have extensive experience in the area of FDA compliance, and we routinely work with companies in the medical device and pharmaceutical sectors.
Homeland Security
While homeland security compliance is paramount for defense contractors, companies in a surprisingly broad array of industries can encounter regulatory hurdles in this area. From banking and finance to cybersecurity and high technology, providing various types of products and services—and serving various types of customers and clients—can have homeland security implications.
Importing and Exporting
Import and export regulations govern matters ranging from the products that are eligible for export (and to what countries) to what is required in order to lawfully import products from foreign companies. In many cases, importers and exporters will encounter regulatory issues involving the Office of Foreign Asset Control (OFAC) as well, and failing to address these issues appropriately can have significant business and legal ramifications.
Medical Devices
Medical devices are subject to regulation by the FDA, and device manufacturers must conduct extensive research and development to ensure that their products are safe for human use. Manufacturers must also be careful when dealing with the FDA (in relation to both approvals and recalls), and they must comply with all pertinent marketing, labeling, and consumer protection requirements.
Medicare, Medicaid, and Tricare
Healthcare providers and other entities that bill Medicare, Medicaid, and Tricare are subject to extensive regulatory requirements. The Centers for Medicare and Medicaid Services (CMS) and DOD work to stringently enforce their respective billing rules and regulations, and providers and other entities accused of violating these rules and regulations can face prosecution for civil or criminal healthcare fraud.
Securities
Federal securities regulations apply to private and public companies as well as brokerage firms, advisory firms, exchanges, and other entities. Non-compliance in this area can also lead to significant negative repercussions, and all entities that are subject to the SEC’s regulatory enforcement authority must devote the necessary resources to establishing, maintaining, and documenting compliance.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Industries We Serve
We serve a broad range of clients in these and other areas of federal regulatory compliance. Our experience spans the full spectrum of industries, and our clients range from technology startups to established healthcare providers and durable medical equipment (DME) companies. Here is just a sampling of some of the industries we serve:
- Alcohol, Tobacco, and Firearms
- Banking and Finance
- Blockchain and Cryptocurrency
- Consumer Products and Services
- Defense Contracting
- Gaming and Gambling
- Healthcare
- High Technology
- Manufacturing
- Marijuana
- Media
- Natural Resources (Land and Offshore)
- Pharmaceuticals
- Oil and Gas
- Renewable Energy
- Transportation
FAQs: Maintaining Compliance in Today’s Dynamic Regulatory Environment
How do companies determine their regulatory compliance obligations?
Identifying all of a company’s regulatory compliance obligations is not an easy process. First, you need to have a comprehensive understanding of the universe of regulations that may apply, then you must determine if these regulations apply to your company based on its size, financial resources, operations, funding sources, and various other factors. With our former federal agents’ extensive regulatory experience, we are able to help our clients efficiently make these determinations.
What is involved in implementing an effective regulatory compliance program?
Implementing an effective regulatory compliance program is similar to addressing any other area of corporate compliance. Once you have a clear understanding of your company’s obligations, the next step is to develop custom-tailored regulatory compliance policies and procedures. With these procedures drafted and in hand, the company can then conduct necessary trainings and execute necessary process improvements, and it can adopt any new technological resources or operational protocols that may be needed as well.
Do federal regulations change?
Yes, federal regulations change, and this presents one of the biggest challenges when it comes to regulatory compliance. Once a company implements a regulatory compliance program, its leaders cannot assume that the program will remain effective over the long term. Companies must monitor for regulatory developments (or engage a consulting firm to monitor for regulatory developments), and they must respond promptly when agencies adopt new rules, prohibitions, and requirements.
How can I make sure my company’s regulatory compliance program remains up to date?
Making sure your company’s regulatory compliance program remains up to date is a matter of monitoring for changes in the relevant regulations and then addressing these changes promptly. At Corporate Investigation Consulting, these are services we provide to our clients so they can rest assured they are not relying on outdated compliance policies and procedures.
What should I do if I have concerns about my company’s regulatory compliance?
If you have concerns about your company’s regulatory compliance, we encourage you to contact us for a complimentary initial consultation. We can help you make informed decisions about what updates and additions to your company’s regulatory compliance program are needed, and we can assist with all aspects of adopting, implementing, enforcing, and maintaining your company’s updated compliance program.
Schedule an Appointment with a Regulatory Compliance Consultant Today
If you need to know more about regulatory compliance, we invite you to get in touch. Please call 866-352-9324 or tell us how we can reach you online to schedule your complimentary initial consultation at Corporate Investigation Consulting.