Services

SUbject Matter expertise

We bring deep regulatory expertise and a holistic approach to compliance, guiding your team in designing, implementing, and optimizing programs that address both foundational requirements and emerging risks.

Our subject matter expertise spans FDA, OIG, CMS, Open Payments, anti-kickback, fraud and abuse, anti-bribery, antitrust, privacy, and cannabis (METRC) regulations. We don’t just interpret rules—we help operationalize them through scalable policies, training, monitoring plans, and privacy program design.

Third Party Risk Management

At INGEN, we help Life Sciences companies streamline and strengthen their Third Party Engagement processes from intake to off-boarding.

We identify gaps in your current workflows, gather cross-functional stakeholder input, and apply industry best practices to design a scalable, risk-based approach. Whether you're building from the ground up or optimizing an existing program, we help implement clear processes, documentation, and supporting tools that drive consistency, transparency, and accountability.

Privacy & Data Protection Services

Navigating global privacy regulations is more critical than ever. We help Life Sciences companies design and operationalize privacy programs that meet evolving requirements while supporting business goals. We work across legal, compliance, and technical teams to implement practical, scalable solutions tailored to your risk profile. We hold several partnerships with other Privacy subject matter experts as well.

TRANSPARENCY REPORTING

With our knowledge expertise, we can help manage your reporting program by utilizing your chosen data management system. Our transparency expertise includes but is not limited to federal and state aggregate spend reporting, disclosure laws, backend data matching, and internal/external data tracking. Using your transparency data to identify key data discrepancies and process improvement opportunities, we will help you optimize your program so that it requires low maintenance in the future.

If you don’t have a data management tool yet, we can help navigate you to a vendor that best suits your needs.

CONTENT DEVELOPMENT

We can develop and implement training to your internal employees, partners and stakeholders on key compliance policies, procedures, practices and requirements for healthcare and related compliance on current enforcement trends. Analyzing your style and brand, we can create training so that matches your company & compliance personality.

MONITORING

We will develop, build and implement a compliance monitoring/auditing program solution for US Commercial and Sales activities to ensure compliance with internal and external policies, laws and regulations.

In additional to building out your annual/quarterly plan, we have the expertise to perform the monitoring ourselves as well. We can help you fulfill both your annual live monitoring and record review expectations (promotional and non-promotional activities).

DATA ANALYTICS

One of the hottest industry topics , we will create analytics dashboards to track, trend and analyze your data observations across activities and business units. Identifying compliance strategies and opportunities, including guidance on additional controls, policies & procedures, training or communication. We utilize Tableau software to create the dashboards and will work with your IT group to employ them on your server so that you have easy access to the data when and where you want.

OTHER

Please contact us if you are interested in learning more about our services or if you have a particular request not listed on this page.

Whether through us or another expert party in our network we can refer you to, your success is our first priority!

Areas of expertise include but are not limited to the following:

• In-depth knowledge of PhRMA Code & Industry regulations

• Privacy & Data Protection

•Third Party Risk Management

•Auditing and monitoring program development

• Data analytics framework design & dashboard implementation

• Global, Federal and State Transparency Reporting

• Compliance Content development

• Compliance SME for product development/market research