Legal Representation for All Areas of Federal Regulatory Compliance and Enforcement
Regulatory compliance is a key aspect of risk management for companies in a broad array of industries. Not only must these companies comply in order to mitigate their risk of consumer lawsuits and other private civil litigation, but they must comply in order to mitigate their risk of facing governmental enforcement action as well. As even identifying a company’s regulatory obligations can prove challenging, it is imperative that companies engage an experienced regulatory lawyer to guide them forward.
A Team of Highly-Experienced Regulatory Lawyers and Consultants
At Oberheiden P.C., our regulatory lawyers provide legal representation for all areas of federal regulatory compliance and enforcement. Additionally, our team includes expert consultants who previously served in high-ranking positions at federal agencies ranging from the U.S. Department of Homeland Security (DHS) to the U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (DHHS). As a result, we have deep experience on both sides of regulatory enforcement matters, and we rely on this experience to provide both effective regulatory compliance representation and regulatory enforcement defense.
Our Federal Regulatory Services
Our federal regulatory services span all industries, from securities to healthcare, and from telecommunications to government contracting. We have experience working with clients ranging from brokerage firms to hospitals, and from venture-backed startups to publicly-traded companies.
Regardless of our clients’ industry or size, we take the same comprehensive approach to our regulatory representation. We ensure that our clients have a clear and complete understanding of their compliance obligations; and, when necessary, we work with federal regulators on behalf of our clients to help them avoid unnecessary adverse consequences.
When it comes to regulatory compliance, one of the biggest challenges is simply knowing where to begin. There are numerous federal regulations, and these regulations are adopted and enforced by an alphabet soup of federal agencies. Companies and firms may have compliance obligations under multiple regulatory regimes, and they may need to adopt policies and procedures that are designed to address a multitude of specific requirements.
Some examples of the areas in which we provide regulatory compliance representation include:
- Consumer Protection Compliance
- Data Protection and Privacy Compliance
- Medicare and Medicaid Compliance
- Environmental Regulatory Compliance
- Office of Foreign Assets Control (OFAC) Sanctions Compliance
- Telecommunications, Transportation, and Utilities Compliance
- U.S. Drug Enforcement Administration (DEA) Compliance for Healthcare Providers and Pharmacies
- U.S. Federal Trade Commission (FTC) Compliance
- U.S. Food and Drug Administration (FDA) Compliance
- U.S. Securities and Exchange Commission (SEC) Compliance
Again, these are just examples. When you engage Oberheiden P.C. for regulatory compliance, we will conduct a comprehensive assessment of your company’s or firm’s obligations, and then we will offer custom-tailored compliance solutions—including policies, procedures, protocols, training, and implementation. We can assist with procurement (i.e., negotiating licenses for data security applications and OFAC sanctions screening software) as well, and our regulatory lawyers can provide compliance insights and advice on an ongoing basis.
As regulatory compliance counsel, our services include:
1. Comprehensive Regulatory Compliance Needs Assessment
We conduct comprehensive regulatory compliance needs assessments that we custom tailor to each client’s business. Relying on our regulatory lawyers’ and consultants’ experience, we make a preliminary assessment of the areas of regulatory compliance that require consideration, and then we conduct a deep dive to identify all pertinent compliance obligations.
2. Regulatory Compliance Advice, Insights, and Counseling
Once we assess your company’s or firm’s needs, then we can provide custom-tailored regulatory compliance advice, insights, and counseling. All of our regulatory lawyers and consultants have senior-level experience, and they rely on this experience to begin guiding our clients from day one.
3. Development of Regulatory Compliance Programs
An effective compliance program is the key to effectively mitigating a company’s or firm’s regulatory risk. We develop compliance programs that comprehensively address our clients’ specific regulatory obligations. We also structure our clients’ compliance programs to facilitate implementation—which can be critical due to the complexity and scope of many of our clients’ regulatory obligations.
4. Regulatory Compliance Implementation, Training, and Procurement
Along with providing advice and developing regulatory compliance programs, we also assist our clients with regulatory compliance implementation, training, and procurement. This continuing representation often proves critical for our clients, as failure to adopt the requisite protocols and procedures can lead to regulatory violations and enforcement action even with written policies and procedures in place.
5. Ongoing Regulatory Compliance Program Management and Needs Re-Assessment
When you choose Oberheiden P.C., you will have access to a senior regulatory lawyer on an ongoing basis. We continue to assist our clients with regulatory compliance program management, and we also re-assess our clients’ regulatory compliance program needs as well. Changes to our clients’ businesses and changes in the governing regulations can both necessitate program updates, and failure to implement these updates can create significant exposure.
A significant portion of our practice is devoted to representing clients in regulatory enforcement matters. We handle enforcement matters involving all federal agencies, from DEA audits and FDA inspections to SEC investigations and OFAC enforcement actions. When facing any type of regulatory enforcement matter, a prompt and proactive response is key, and executives and directors must be able to rely on their company’s or firm’s counsel to strategically guide them forward.
The potential outcomes of regulatory enforcement matters can vary greatly depending on the agency and allegations involved. Loss of registration, civil monetary penalties (CMP), injunctions, and bars from doing business in certain industries may all be on the table. When representing clients in regulatory enforcement matters, we intervene quickly to understand the scope and nature of the issues at hand, and then we structure our clients’ defense strategies based on the specific risks involved.
Too often, companies and firms try to handle regulatory enforcement matters on their own. While this may seem prudent initially, as initial communications from regulatory agencies may appear relatively inconsequential, enforcement matters can quickly expand beyond what companies and firms can handle in-house. The scope of the risks involved can also far surpass companies’ and firms’ internal capabilities. Engaging experienced regulatory counsel from the outset is critical, and our regulatory lawyers are available to provide representation on an emergency basis when necessary.
FAQs: Regulatory Compliance and Enforcement in the U.S.
What Are Some of the Most Common Areas of Federal Regulatory Compliance?
While there are numerous areas of federal regulatory compliance, some of the most common areas of concern for companies and firms are securities compliance, consumer protection compliance, and data privacy compliance. All of these compliance obligations can apply regardless of a company’s or firm’s industry, and regardless of whether an entity is private or publicly traded.
How Can Companies Assess Their Federal Regulatory Compliance Obligations?
To comprehensively assess their federal regulatory compliance obligations, companies need to work with experienced compliance counsel. There are simply too many areas of compliance for companies to effectively assess their obligations on their own. At Oberheiden P.C., we work closely with our clients to gain an understanding of their corporate structure, business operations, and customers, and then we use this information to systematically identify all pertinent federal regulations.
What Are the Risks of Failing to Maintain Federal Regulatory Compliance?
The risks of failing to maintain federal regulatory compliance can be substantial. Civil monetary penalties for regulatory violations can add up quickly—into the millions or even billions of dollars in many cases. Regulatory violations can also cause federal agencies to intervene and prevent companies and firms from engaging in certain business or commercial activities. As a result, companies and firms need to prioritize regulatory compliance, and they need to be confident that their business and commercial activities are not creating exposure to unnecessary enforcement risks.
How Can a Federal Regulatory Lawyer Help My Company?
A federal regulatory lawyer can help your company by comprehensively assessing its compliance obligations, developing the policies and procedures necessary to address these obligations, and providing compliance advice on an ongoing basis. A federal regulatory lawyer can also provide representation for interactions with government agencies as necessary. At Oberheiden P.C., we provide full-service regulatory representation for our clients with respect to both compliance and enforcement defense.
What Should I Do if I Have Been Contacted By a Federal Regulatory Agency?
If you have been contacted by a federal regulatory agency, you should consult with an experienced regulatory lawyer promptly. Regulatory enforcement actions can progress quickly, and situations that should be manageable can quickly become unmanageable in the absence of a coordinated and strategic approach. While regulatory enforcement actions can present significant risks, it is also possible to favorably resolve these actions without fines or other penalties in many cases.
Speak with a Senior Regulatory Lawyer at Oberheiden P.C.
If you have questions or concerns about your business’s federal regulatory compliance obligations, we invite you to get in touch. We provide regulatory representation to companies and firms across the United States. To speak with a senior regulatory lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or request a complimentary initial consultation online today.