Our mission

To provide every client with confidence in the effectiveness and efficiency of their compliance program.

Our Services

DI MAURO COMPLIANCE CONSULTING (“DCC”) PROVIDES SERVICES TO SMALL AND MID SIZED PHARMACEUTICAL AND BIOTECH COMPANIES IN RISK ASSESSMENT, MANAGEMENT AND IMPLEMENTATION.

Risk Assessment


All organizations have risk and a risk tolerance profile. Is your risk in harmony with your risk tolerance?

DCC provides services to assess the current state of your compliance program and to develop a program that harmonizes your standards and values with your processes.

Federal & State Reporting


Timeliness and accuracy are critical to the ongoing submission of federal and state disclosure reports. The process is time consuming but reporting is a requirement. Is your process efficient and inclusive of all required reporting information? How can the data be leveraged to bring value to your business?

DCC provides services to ensure that your Federal (Open Payments) and State Disclosure requirements are achieved timely, accurately, completely and efficiently.

Systems and Processes


Implementing technology solutions can be an opportunity for cost savings and efficiency or it can result in a waste of resources.

DCC provides services to identify solutions that balance technology and your compliance and business objectives.

Written Policies and Procedures


Employees of high performing organizations know what the organization expects of them. Do your employees know what is expected of them?

DCC provides services to ensure your Code of Conduct, Policies, and Procedures reflect your practices and more importantly your standards and values.

Prescription Drug Marketing Act


Pharmaceutical Sample Accountability and Reconciliation is a costly activity and has been a requirement for decades. When was the last time you reviewed your program for efficiencies?

DCC can review your program to determine if the compliance program is executed to meet regulatory goals and also provides the best business benefit from an efficiency perspective.

Disciplinary Guidelines and Process


Your comprehensive compliance program should include a process for the investigation of potential violations of laws, regulations and company policy. The process should include a written policy and a process for responding promptly. Expectations for personal responsibility and the manager responsibility should be included in your training curriculum.

DCC provides services to assess and remediate gaps in your disciplinary process and to design tools for ongoing evaluation of data trends over time to ensure organizational risks are identified and remediated.

Communication, Training and Education Programs


Training and communication failures result in execution failures. Program success is dependent on content development, effective communication of requirements and documented confirmation of training completions. All of these program elements are equally important.

DCC provides services to assess the current state of your communication strategy and compliance training program. DCC will work with you to identify your gaps and your opportunities for improvement.

Internal Auditing and Monitoring of Sales and Marketing Activities


Trust but verify is an important principle of compliance. A Compliance Program should incorporate mechanisms to ensure key metrics are tracked for exceptions. Detecting problems and undertaking corrective action is important to the integrity of your program and your Company.

DCC provides services to assess current metrics and provide recommendations to remediate gaps or design and implement a new Auditing and Monitoring Program.

 

About

Successful Compliance Professional with 25 years of experience in large and small pharmaceutical environments. Expert in implementations of all facets of the Office of Inspector General guidelines related to the Seven Elements of an Effective Compliance Program.

Mary Di Mauro

President

PDMA Alliance

Past President, Vice-President and Treasurer of the Pharmaceutical Industry Trade Organization focused on compliance with the Prescription Drug Marketing Act.

Awards

Merck Division Award (2002) – Implementation of Electronic Data Capture in the Merck Field Sales Force resulting in $4M annual savings

Merck Division Award (2008) – Implementation of CIA which was a complex cross-functional initiative involving aggressive timelines and reputational impact

Merck Division Award (2011) – Implementation of Post Integration External Reporting Process resulting in $500K savings/cost avoidance

Six Sigma Black Belt

Six Sigma Award – Selected the top Black Belt Sigma Project in the Merck Global Compliance division and in the top five simplification projects for eligibility screening and external reporting for Merck in 2011.

Merck’s Most Amazing Woman

Recognized for individual achievements and contributions to the advancement of women in business

Get in touch

For more information related to services, please contact us by phone or email. Thank you.

Let us know how DCC can help you

  • Durham, NC
  • Phone: 919-864-9377
  • mary@dimauroconsulting.com

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