Managed Services

Business Support for Life Science Companies of All Sizes

Federal Compliance Solutions (FCS) supports pharmaceutical and biotechnology companies of all sizes with a wide range of day-to-day operational processes and ongoing compliance requirements. By working as an integrated extension of your team, our best-in-class service delivery model utilizes cloud-based, SOC-compliant technology and a team of pricing and contracting experts.  FCS has also developed automated processes to ensure accurate and timely payment of your contractual rebates and fees which include bots for invoice retrieval, analytical dashboards, and electronic approvals to capture client authorizations.

FCS offers comprehensive business support unlike any competitor. In addition to flawlessly executing operational requirements such as master data management and class of trade assignment for government pricing calculations, we offer strong advisory support and strategic direction across the full spectrum of business needs. Our consultative team comprises eminent subject matter experts and strategic advisers who can provide guidance and execute on an array of operational compliance requirements. We ensure our clients are informed and have full visibility to results of processed rebates and government price calculations so they can confidently release payments and certify results.

We strive to not only help our clients improve day-to-day operations, but we can integrate our contract rebate processing results and government pricing calculations with Gross-to-Net models so clients can see the full picture of how Government Pricing and rebates impact the bottom line.  This allows our clients to enhance their current business strategies across areas such as finance, accounting, data analytics, IT solutions, market access, commercial pricing, and contract operations.

Comprehensive Services For Today’s Life Science Industry

FCS’s detailed, high-quality reporting is the gold standard in the industry. Our proprietary, SOC-Certified system retrieves and validates critical data. Our managed services experts perform vital calculations and reporting on a monthly and quarterly basis to assist with a myriad of business matters, including:

  • Government Pricing Calculations & Reporting Services
    • SOPs and Methodologies for government reporting and pricing computations 
    • Class of Trade assignment and 340B validations
    • Customer and Product domain data management
    • Systems to generate government pricing computations and submissions to appropriate federal and state regulatory authorities
      • Average Manufacturing Price, Best Price, Unit Rebate Amount 
      • 340B Ceiling Price
      • Medicare Part B – Average Selling Price
      • State price report for Texas, California and New Mexico
  • Rebate and Fee Services
    • Medicaid drug rebate processing
    • Tricare program rebate processing 
    • Medicare Part D Coverage Gap rebate processing
    • GPO Admin and Distributor fee processing 
    • Commercial/PBM rebate processing
    • Formulary Compliance & Verification
    • Validation and dispute resolution
    • Banking services and payment processing
  • Veterans Administration Support
    • SAM.gov setup and ongoing contract administration
    • Federal Supply Schedule interim agreement & national award contracting
    • NonFederal Average Manufacturing Price, Federal Ceiling Price
    • VA Sales Reporting and IFF payment processing
  • SPTR
    • Product and Wholesaler Acquistion Cost (WAC) domain management
    • Automated quarterly and annual state price transparency submissions
    • Tracking and notices of filing and fee payments
  • FMV & BFSF Support
  • Gross-to-Net Forecasting & Accrual Management
  • Advanced Technology

What You Get with Our Advanced Platform

Data Retrieval

At Federal Compliance Solutions, we understand the importance of timely and accurate data retrieval for life sciences companies. To ensure seamless data collection, our team has developed custom bots capable of performing automated data retrieval from various sources, including 3PLs, SFTP servers, State Portals, and other websites. These bots enable us to extract data in a consistent and reliable manner, while also adhering to a regular schedule.

By leveraging our advanced data retrieval capabilities, we can significantly increase the speed at which we deliver services to our clients. This allows life sciences companies to focus on their core business activities while maintaining compliance, knowing that their data is being collected and processed efficiently and effectively by our web-based application and data processing platform.

ETL

At Federal Compliance Solutions, we acknowledge the challenges that life sciences companies face when dealing with diverse data sources, including both paper invoices and electronic data. To overcome these hurdles, we have developed a sophisticated ETL (Extract, Transform, Load) pipeline capable of transforming disparate data sources into a standardized format.

Our ETL pipeline is designed to handle various types of data input, allowing us to load your data into our data processing platform with minimal intervention from users. To process physical copies of data, we utilize advanced image recognition technology that efficiently extracts information from paper invoices and other documents. This ensures that all data, regardless of its original format, is consistently structured and ready for analysis, reporting, and compliance checks within our platform.

By employing a powerful and adaptable ETL process, we empower life sciences companies to concentrate on their core objectives while trusting that their data is being managed effectively and accurately by our web-based application and data processing platform. 

Audit and Compliance Ready

At Federal Compliance Solutions, we understand the critical role that audit and compliance play in the life sciences industry. That’s why we’ve designed our systems to meticulously track and record all changes made to data and business methodologies within our platform.

Our audit-ready systems have the unique ability to regenerate calculation results at a later date, as if the calculations were being performed on the original day they were generated. This retrospective capability ensures that you can maintain a comprehensive audit trail, providing complete transparency and accountability for all data and calculations.

With our web-based application and data processing platform, life sciences companies can have confidence in their compliance readiness, knowing that our systems have been designed to meet the stringent requirements of their industry. This allows you to focus on your core business activities, while we take care of the data management, processing, and compliance aspects.

Secure Storage and Archiving

At Federal Compliance Solutions, we prioritize the security, privacy, and long-term accessibility of your data. Our platform employs state-of-the-art secure storage and archiving practices, ensuring that your sensitive information is always protected and available when needed. We use the latest encryption technologies to safeguard data both at rest and in transit, providing peace of mind for our life sciences clients.

To further enhance data security, we store original data in a location that can be securely accessed by our clients, ensuring that you have full control over your information. Moreover, our systems are designed with a single-client configuration, effectively eliminating the risk of mixing data from different clients.

In addition to secure storage, our platform features robust archiving capabilities, allowing for efficient long-term data retention and retrieval. This ensures that your valuable information remains accessible and well-organized, even as regulatory requirements and industry standards evolve over time.

By implementing comprehensive data security measures and following industry best practices for storage and archiving, we strive to provide a reliable and secure web-based application and data processing platform that life sciences companies can trust for their data management, processing, and compliance needs.

Approval Workflow Process

At Federal Compliance Solutions, we prioritize the control and accuracy of data submissions to state and federal agencies, as well as the payments made through our banking integrations. To achieve this, we have implemented a comprehensive approval workflow process that is integrated with our secure data storage system.

Our approval workflow is designed to allow one or more approvers to review and indicate acceptance of reports and payments before they are submitted or initiated. The process supports various forms of approval, including electronic signatures, ensuring flexibility and adaptability to meet your organization’s specific needs.

By incorporating a robust approval workflow, we guarantee that our customers have the final say on all reports and payments that are submitted or processed. This ensures that your data and financial transactions are handled accurately and securely, providing you with the confidence and peace of mind that your regulatory and financial obligations are being managed efficiently by our web-based application and data processing platform.

Payment Integration

Federal Compliance Solutions recognizes the value of seamless financial transactions for life sciences companies. That’s why we have established integrations with a leading bank, enabling our platform to automatically make payments on your behalf through various methods, such as ACH transactions or by generating and mailing checks.

Our payment integrations are built directly into our web-based application and data processing platform, streamlining the process of making payments to states and other trading partners you work with. By automating the payment process, we help you save time, reduce manual effort, minimize the risk of errors in your financial transactions and ensure timely delivery.

With our secure and efficient payment integration solutions, life sciences companies can trust that their financial transactions are being handled accurately and promptly. This allows you to focus on your core business activities, while we take care of the payment processing and compliance aspects within our platform.


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