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When you’re facing a federal issue, you need an attorney whose going to be available 24/7 to help you get the results and outcome you need. The value of working with the Spodek Law Group is that we treat each and every client like a member of our family.

Internal Investigation & Compliance – Pharmaceutical Marketing & Sales Lawyers

In today’s complex business world, internal investigations, or audits, for compliance are mandatory to maintain a health company. Not only can audits strengthen a company’s relationship with its employees, but they can also foster a culture of compliance. Putting this into perspective, compliance keeps your company out of federal crosshairs.

Typically, the focus of compliance audits is narrow and defined. Nevertheless, it can cause concern among your employees. Documentation, visual inspections and employee interviews are guaranteed parts of the process. Questions about the work they perform can create internal tension among your workforce unless misunderstandings are handled correctly.

Since internal compliance is a critical aspect of running a solid business, using a third-party service with an objective view is probably best.

Understanding an Internal Investigation and Compliance Audit

George FernandezGeorge Fernandez
14:16 30 Apr 24
Excellent 10 out of 10, Helped resolve my case. Jeremy explained everything and made everything easy to understand.
21:33 24 Apr 24
If you are looking for a lawyer that listens, is aggressive where needed, and holds his word above all else, Todd is the best pick. I had hired multiple attorneys prior to hiring the Spodek Group for a white collar case. The first thing that stood out to me was the cost, as anyone going through the process and dealing with the system, money was tight at that time - especially after hiring and firing multiple lawyers. The cost was not as high as others which was definitely a plus. Todd's intake process was also unlike other attorneys. He took the time to actually listen. He cared. He was trying to put himself in my shoes while I was explaining the situation to him and he really took the time to understand the whole situation. Other lawyers will give you 15 mins and send you a retainer agreement. Not Todd, I think he spent almost two hours with me as I was explaining everything.Not only was he great during the onboarding process, he was supportive and very informative through the entire plea process and eventually sentencing. After hiring him, I asked if I should hire a prison consultant, he told me to save my money as he would do everything they would. He was right and held up to his word. Later on I would hear from others that went with the prison consultants that they were a waste of money - I am glad I listened to Todd!When it came time for sentencing, two days prior to sentencing, the prosecutor tried increasing my proposed prison time by almost double - apparently a normal move. Todd and his team worked with me non-stop through the weekend prior to sentencing to ensure that I was not given additional prison time. Again, he took the time to listen and came up with a strategy to explain the case with great detail.Unfortunately, I did plead guilty as that was my best option. Todd and his whole team wrote up nearly 300 pages of a summary of what happened and why I should not be given prison time. If I breakdown the amount I spent with Todd versus the amount of work that I saw being done, I am shocked I was not charged four times as much. The other benefit was, a lot of criminal defense lawyers were just a single attorney with a paralegal or two. Todd had a team of people that I dealt with (5-7 people that I interacted with), but he was ALWAYS accessible. It would never take him more than an hour to reply unless he was in court.I was sentenced to prison and I was emotionally distraught. Todd and his team did whatever they could even after sentencing to make sure I was alright. He personally stayed in touch with my family to ensure I was doing alright and offered support to them. Most lawyers would consider the job complete at sentencing, not Todd.After prison, Todd still spent time with me to make sure I was on the right track and avoiding any potential risks in the future. He has also been giving advice on how to navigate probation etc and has not been looking at the clock for billing.Although I wish I had never been arrested in the first place, I am glad I had Todd and his team in my corner. Without them I likely would have had to spend a lot more time in prison than I did.Thank you, Todd, and the entire Spodek Law team, for helping turn what was a nightmare into a manageable situation!
Yelva Saint-PreuxYelva Saint-Preux
19:26 19 Apr 24
I am immensely grateful to the entire team at Spodek Law Group for their unwavering dedication and exceptional expertise throughout my case. From our initial consultation to the final resolution, their professionalism and tireless advocacy made all the difference. Their strategic approach and attention to detail instilled confidence in me every step of the way.Thanks to their hard work and commitment, we achieved a truly favorable outcome that exceeded my expectations. Not only did they navigate the complexities of my case with precision, but they also provided invaluable support and guidance during what was undoubtedly a challenging time. I cannot recommend Spodek Law Group highly enough, especially attorneys Todd Spodek and Claire Banks; they are beacons of excellence in the legal profession.YSP.
Katherine SunKatherine Sun
18:08 18 Apr 24
my lawyer is Alex Zhik. Efficient, patient and professional
Nun yaNun ya
17:48 18 Apr 24
Todd, Ralph and Alex are amazing. Helped my husband get from a double digit number with multiple charges to a single digit, by the time I blink he will be out. They very professional and help with all your needs. They dealt with my anxiety and worry very well and they understand that your family member needs to get home as soon as possible.
Keisha ParrisKeisha Parris
20:45 15 Mar 24
Believe every single review here about Alex Z!! From our initial consultation, it was evident that Alex possessed a profound understanding of criminal law and a fierce dedication to his clients rights. Throughout the entirety of my case, Alex exhibited unparalleled professionalism and unwavering commitment. What sets Alex apart is not only his legal expertise but also his genuine compassion for his clients. He took the time to thoroughly explain my case, alleviating any concerns I had along the way. His exact words were “I’m not worried about it”. His unwavering support and guidance were invaluable throughout the entire process. I am immensely grateful for Alex's exceptional legal representation and wholeheartedly recommend his services to anyone in need of a skilled criminal defense attorney. Alex Z is not just a lawyer; he is a beacon of hope for those navigating the complexities of the legal system. If you find yourself in need of a dedicated and competent legal advocate, look no further than Alex Z.
Taïko BeautyTaïko Beauty
16:26 15 Mar 24
I don’t know where to start, I can write a novel about this firm, but one thing I will say is that having my best interest was their main priority since the beginning of my case which was back in Winter 2019. Miss Claire Banks, one of the best Attorneys in the firm represented me very well and was very professional, respectful, and truthful. Not once did she leave me in the dark, in fact she presented all options and routes that could possibly be considered for my case and she reinsured me that no matter what I decided to do, her and the team will have my back and that’s exactly what happened. Not only will I be liberated from this case, also, I will enjoy my freedom and continue to be a mother to my first born son and will have no restrictions with accomplishing my goals in life. Now that’s what I call victory!! I thank the Lord, My mother, Claire, and the Spodek team for standing by me and fighting with me. Words can’t describe how grateful I am to have the opportunity to work with this team. I’m very satisfied, very pleased with their performance, their hard work, and their diligence.Thank you team!
K MarK Mar
01:37 25 Jan 24
I recently had Spodek Law Group represent me for a legal matter in NYC and I am thoroughly impressed with their services.Alex Zhik secured the best possible outcome for my case.It was a seamless journey from the initial consultation to the resolution of my legal matter. From the moment I spoke to Todd about my case, his enthusiasm to help was evident, setting a positive tone for the entire experience. The efficiency and professionalism displayed by the team is commendable.A particularly noteworthy aspect of their service is their user-friendly portal to upload your documents/evidence. This not only simplified the process, but showcases their commitment to streamline the client experience.Lastly, in an industry where legal fees can often be a concern, I found their pricing to be very reasonable, making needing legal assistance feel accessible and stress-free.I am grateful for their support and wouldn't hesitate to turn to them again in the future.

Defining internal audits is helpful to understand the relationship to ensuring compliance. Whether your business is publicly held, privately owned, nonprofit or for-profit, internal reviews of operations is required on a regular basis.

Some reviews are legally required; others are simply best practices. Either way, the results can help you maintain a healthy functioning company and avoid penalties and fines due to noncompliance.

Types of Internal Compliance Audits

Basically, there are four types of internal audits. Industry, location, and, entity and regulatory requirements for your company distinguishes the type of audits you need.

• Contractual audits are designed to ensure that your company complies with customer specifications in contract requirements.
• Governmental audits are for companies – usually nonprofits – that receive grants or other types of funds that include contractual obligations.
• Industrial standards may apply to health care facilities and compliance with HIPAA regulations. Food handlers is another industry that have health regulations with constant oversight to ensure food safety standards are met.
• Risk management relates to workplace safety where compliance audits and constant monitoring are the norm.

Crimes revealed are often some form of theft or fraud. However, rarely will a company support prosecuting the employee or employee involved because they want to avoid bod publicity. If noncompliance with OSHA regulations results in severe injuries or death, a criminal charge will most likely follow.

Laws Governing Compliance Audits

Currently, there are no laws that specifically address internal compliance audits. However, a combination of these audits may fall within broader legislative guidelines. President Bush signed the Public Company Accounting Reform and Investor Protection Act of 2002 to deal with internal auditing and publicly held companies.

Internal auditing functions were greatly expanded under this Act. Senior management must sign off on all financial audits and the responsibilities of the Board of Directors increased. While financial audits are the focus of this Act, it does highlight the importance of self-policing for every company.


Penalties and punishments for violations that are uncovered by an internal compliance audit may vary based on the type of violation. Typically, when something violates the law, it will apply to civil statutes. Fines and court levied injunctions against the company are usually the resulting punishment.

For pharmacological companies, adhering to strict marketing guidelines is very important. Patients and doctors rely on the information these companies share, including advertising, to make decisions about different treatment options.

The United States has laws to address the relationship that sales representatives have with medical professionals. These include:

• Anti-bribery laws
• False Claims Act
• Food, Drug and Cosmetic Act
• U.S. Foreign Corrupt Practices Act

Pharmacological companies are encouraged, as well as expected, to follow these laws.

Pharmaceutical Marketing & Sales

In addition to following specific laws, pharmaceutical companies should remain proactive in monitoring and preventing unethical practices. Having strong sanctions in place may help to prevent specific behavior by representatives that could lead to a costly violation.

A self-regulating system can also help to ensure internal compliance audits will work in favor of the company. If potentially risky practices are revealed by an audit, implementing changes to reduce those risks should occur without delay.

Hire a Strong Legal Advocate

Hiring a strong legal advocate from Spodek Law Group, PC can help you expose any issues with compliance. Even if jail time is not part of the penalty for noncompliance, you want to avoid paying hefty fines. Whether you are a pharmaceutical company or other type of company, call us today so we can begin working towards the best possible outcome for your company.

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