01 — Monitoring

One of the major challenges for life science companies is the monitoring of activities. The staff does not only have difficulties in executing the required activities due to insufficient training, but a major missing factor is the time and the knowledge needed to develop a solid monitoring program .

We at Dima Compliance Solutions are specialized in the creation of monitoring programs and we are here to create a program based on your organization’s specific needs. Not only are we helping you to ensure that your organization is operating in accordance with applicable laws and internal guidelines, but over our review process, we are also able to identify further areas for improvement.

Due to our experience in leading US Department of Justice (DOJ) monitorships and creating effective compliance programs, we know how to build a solid line of defense to protect your company from misconduct and failure to adhere to compliance requirements. With our knowledge as an independent monitor, the program can turn into your go-to-tool in identifying pain-points and preventing your organization from fines and penalties.

Moreover, we are able to train your team to independently execute monitoring activities and create a program based on risk-focused indicators, in order for you to have immediate assistance by your side when the risk arises.

02 — Communication

How often do you wonder what it would take to create a compliance culture within your organization that is fully endorsed and supported by the management and especially the sales team? We are experiencing that most companies although having a fully staffed compliance department lack the proper communication skills. Thus, interpersonal relationships with other stakeholders, suffer due to the absence of trust in the compliance team. This not only creates gaps in the communication of the underlying compliance message, but also does not allow the department to create a vision that focuses on integrity.

A key mechanism for building a successful compliance program are effective communication skills. We support you in the development of compliance officers with training that is based on individual needs. Firstly, we identify the areas of improvement on an individual basis, and then we jointly create a plan for overcoming personal challenges.

Our goal is to create officers that are welcoming discussions with stakeholders, proactively support them, are happy to brainstorm about complex business requests and foster strong relationships.

03 — Compliance Program Implementation and Evaluation

From our experience as inhouse and external advisors, we understand that the benefit of “nothing happened in the past” in your organization can turn into your biggest challenge as a compliance officer. This fact may put the organization in an excellent position with an untarnished reputation, but how can you demonstrate to your management that the evaluation and improvement of the compliance program is necessary?

We support you with highlighting the needs for a compliance program and identify actions for development that are necessary for a solid program. As the laws and regulations are getting stricter and fines are getting higher when a compliance misconduct happens, building a compliance program is not enough - if it is not effective. We help you to evaluate and review your compliance program based on the company’s risk profile, securing that the program is solid and has been communicated and understood by stakeholders in practice.

04 — Compliance Policies and Procedures

Policies, processes and procedures are not only one of the key elements of the US Department of Justice Guidance, Evaluations of Corporate Compliance Programs, and a major component in ISO certifications, but also the basis of your compliance program. These documents count as one of the main preventive measures, and should be well-integrated into the company’s operations and workforce.

We design and improve risk-based policies and procedures, and aim for realistic business-oriented processes. Moreover, we support you throughout the complete cycle from the policy creation to incorporation of the policies in the business’s day-to-day operations.

In case you are a local company, which follows policies from the headquarters, we also help you to ensure that these policies catering to local laws and internal procedures match the local regulation. After identifying the relevant laws and regulations, we support you in ensuring a common ground with your local key stakeholders and getting their opinion on board. In this way you acquire your stakeholders’ support and ensure a smoother roll-out.

We also create a curriculum that ensures employees understand the procedures. With our extensive knowledge in developing and improving policies and procedures, we help you create a framework that is focused in providing benefit to all stakeholders with clearly described action steps that are based on applicable requirements, laws and regulations.