Customized Compliance Solutions
Our focus is to provide cost-effective and sustainable solutions. We understand that the best way to ensure compliance is to have full buy-in from all team members and we know that no two teams are the same. This is why we provide solutions that are specifically designed for our clients’ unique needs. Our team has an in-depth understanding of the pharmaceutical industry and utilizes this knowledge to craft solutions that are both practical and meaningful. Our experience has shown that when compliance strategies fit into daily routines, a culture of compliance is easy to build.
Industry demands for either increased compliance efforts or adherence to new regulations and guidelines are constantly changing. Company resources can become limited and full time recruiting efforts take time. We can help. Our team has a wide range of experience providing supplemental support to several business functions in the life sciences industry. Whether clients are in need of short term staffing to meet an Open Payments deadline or require long term staffing support with sales force activity compliance or policy and procedure development, our team offers highly specialized, lower cost staffing solutions to meet your needs.
Compliance and Operational Risk Assessments
Assessments of your company’s operations are a critical part of all meaningful compliance programs. Recent Corporate Integrity Agreements (CIAs) have affirmed that regardless of company size, the Office of Inspector General (OIG) expects proactive risk evaluations to be part of all compliance programs. Our experts conduct risk assessments by first truly understanding how your business operates. After learning the nuances of your business, our team will analyze and benchmark your operations against prevailing industry standards and relevant recent trends. As the end result, you will be provided with an objective and standardized risk analysis.
We view ourselves as your partner and treat your business with the same care as we treat our own. We know that our own success is measured by the success of our clients.
Market Access Strategy
Without appropriate market access even the best products will fail. Today, market access strategies are filled with numerous business and compliance pitfalls. You need a market access advocate in your corner to help navigate this complex and long ranging problem area. Our team has experience working with brands of all sizes and at all life-cycle stages, enabling us to provide your business with the advice you need. We understand the nuances of the marketplace and government pricing regulations and we are not afraid to give you the advice that you need to hear.
Auditing and Monitoring
Meaningful compliance requires auditing and monitoring of actual operations. At its core, compliance really is a measurement of how precisely your company’s real world operations align with your company’s statement of those operations in policies and procedures. The most sophisticated policies and procedures do not amount to much if they are not actually being followed.
Our team of experts has experience developing and implementing auditing and monitoring programs in both large and small operations. They understand the challenges companies face from both practical and legal/regulatory perspectives, and help companies explore and implement auditing and monitoring processes to avoid potentially costly compliance issues.
Training is the heart of all meaningful compliance programs. Without adequate training, it is unfair and unreasonable to expect your team members to know what your company expects from them. We’ve learned that once employees are given the wisdom to know right from wrong, they will instinctively choose the correct path.
Our staff is more than experts; they are also teachers. We know that knowledge is power and we specialize in providing compliance trainings to teams of all sizes and from all business units. Our experts have experience providing trainings to all levels of the corporate structure – from sales staff to executive management.
Remediation and Mitigation
Compliance risks and problems can arise in any business area. Meaningful compliance requires businesses to take action once a compliance risk or problem area is discovered. Our team of experts has wide ranging experience solving all types of compliance problems. No matter the size of the issue, our team will find solutions that work for your business. We understand that effective problem solving requires a deep understanding of how and why the issues exist. With this understanding, we are able to craft solutions with clients that are practical both in the short term and the long term.
Legal Expert Advisory Services
Our team features a number of US licensed attorneys with significant top-tier US law firm practice experience representing pharmaceutical and medical device companies in high profile government investigations and seminal litigation involving numerous national and international laws and regulations. While we do not provide legal advice, we are intimately familiar with the legal complexities of the life science industry. We work with our clients’ internal legal departments and outside counsel to reduce legal spend by offering cost effective pre-trial preparation/investigation, discovery management, forensic document/activity analysis and more.