Regulatory Operations and Reporting Managed Services

Today, companies face the challenge of effectively managing program initiatives and an increasing array of third-party vendors to deliver strategic products and services. This ecosystem requires you to adhere to rigorous regulatory standards and industry best practices, while carrying out your work and reporting to stakeholders.

To help you address this challenge, our Regulatory Operations and Reporting Managed Services can help support your day-to-day regulatory demands. This allows you to stay up-to-date and in compliance, while also pursuing innovative and “out of the box” operational and reporting solutions. With our assistance, you can focus on driving innovation and achieving growth.

Regulatory Operations
Transparency Reporting

Regulatory Operations

Performing regulatory operational functions, such as assessments, vetting options, procurement support, monitoring activities and processing payments, is crucial. However, these activities can be demanding, iterative and time-consuming, diverting resources from your team's responsibilities that fuel growth.

In highly regulated sectors like Pharmaceutical and Life Sciences, additional complexities arise, such as conducting multi-dimensional needs assessments, engaging healthcare professionals, comparing expert rates against fair market value scales and tracking these engagements.

To address these challenges, we have invested in proven technology products and AI approaches that align with regulatory requirements. These tools are designed to expedite the delivery of sustainable and scalable operational solutions.

With our blend of industry and process expertise, PwC can help you leverage automation and assume the operational and support tasks you face, prioritizing efficiency, effectiveness and cost containment. This allows you to retain decision-making authority, while we streamline your operations.

Transparency Reporting

Transparency reporting across industries and functions reflects a common theme of public communication and documentation of key metrics and information about the business.

These initiatives range from reporting corporate ownership and controlling interests to the US Treasury to itemizing and reporting transfers of value from pharmaceutical manufacturers or drug device companies to healthcare professionals and organizations to CMS.

Regulators are increasingly “auditing” reporting to ensure the target data is presented in an accurate and timely fashion – and collecting fines when it is not.

PwC has created acceleration tools to collect and process the data, power reporting and support analytics that facilitate comparing trends, isolation of exceptions and unexpected results.

Our process and industry-oriented, “white glove” teams will help you establish and customize these solutions for your business – presenting you with output which the business can confidently support and officially “attest.”

Contact us

Nathan Lebowitz

Principal, Pharmaceutical and Life Sciences, Compliance Solutions, PwC US

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Regulatory Operations and Reporting Managed Services