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KPMG Health Authority Inquiry (HAI)

Gain greater efficiency, visibility, and control in the HAI process

KPMG Health Authority Inquiry (HAI) can help

Life sciences companies receive thousands of inquiries per year from healthcare authorities. Responding requires enormous financial and labor resources, and the process is burdened with inefficiencies. Manual input can introduce the possibilities of errors and redundancies. 

The KPMG Health Authority Inquiry (HAI) accelerator is designed to streamline the process. Assisted by AI, HAI automates the inquiry intake and helps classify and assign questions to the right subject matter experts. Insights from similar past questions and responses are easily available to aid in response generation.

HAI also offers translation capabilities so, no matter what the language of the inquiry, they can be responded to in a timely manner. Through intuitive and easy-to-use dashboards, users now can simplify and speed up the inquiry process, save time, reduce potential errors, and gain greater control.

Potential benefits of KPMG Health Authority Inquiry (HAI)

KPMG HAI allows organizations to build a repository of searchable questions and their responses that users can leverage for future inquiries. In doing so:

1

Responses become more consistent and there are fewer knowledge gaps or errors.

2

Efficiency gains give time back to your employees.

3

Workflows between systems are improved.

4

Health Authority-mandated timeframes are met. 

5

Complex manual activities are automated. 

6

Global queries receive timely response, no matter what language.

7

Reports are tailored to give you greater visibility into cycle time metrics, submission performance, and AI performance

KPMG Health Authority Inquiry (HAI) is fully automated for speed and efficiency

HAI requests are automated. When a health authority inquiry arrives, AI scans the request for relevant information like due dates, which health authority sent it, which application or product it references, and more. The tool then creates a structured record and assigns it to the appropriate Inquiry Owner.

From there, the Inquiry Owner confirms intake and assigns it to a Response SME who looks up similar questions, drafts, and finalizes a response, which KPMG HAI stores and marks the inquiry closed.

Streamline your approach to the Health Authority Inquiries process

1. Watch our video:

See how the KPMG Health Authority Inquiry (HAI) accelerator can help create greater efficiency, visibility, and control in the HAI process while reducing risk and improving regulatory strategy.

Coming soon!

2. Read about the benefits:

At KPMG, we bring together our Technology, Risk, and Compliance teams to help life sciences organizations transform how they manage Health Authority inquiries. With our Health Authority Inquiries (HAI) accelerator, we automate the intake of regulatory correspondence, streamline workflows, support consistent response drafting using client-approved templates, and build a smart, searchable repository of past inquiries and responses to improve future decision-making. Our deep industry expertise and proven transformation methodologies ensure that clients not only implement the right tools but also evolve their processes to reduce manual effort, minimize regulatory risk, and enhance response quality across their global operations.

Read more 

3. See the advanced outcomes:

Faced with limited visibility and inefficient tracking, a global pharmaceutical company struggled to manage Health Authority Inquiries (HAIs), making regulatory compliance reporting difficult. KPMG implemented an automated intake solution that streamlined workflows, enabled automated responses, and maintained a comprehensive historical record for future reference. 

Within just three months of go-live, the solution successfully processed over 3,500 HAIs and supported more than 1,000 regulatory end users across the globe—transforming compliance operations with speed, scale, and confidence.

Read more

Meet our team

Image of Sean Berquist
Sean Berquist
Advisory Managing Director, KPMG LLP
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Image of Brian Williams
Brian Williams
Managing Director, Life Sciences Advisory, KPMG US
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Image of Sean Berquist
Sean Berquist
Advisory Managing Director, KPMG LLP
Read bio
Image of Brian Williams
Brian Williams
Managing Director, Life Sciences Advisory, KPMG US
Read bio

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Some or all of the services described herein may not be permissible for KPMG audit clients and their affiliates or related entities.

The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation. KPMG LLP does not provide legal services.

The information contained herein is not intended to be “written advice concerning one or more Federal tax matters” subject to the requirements of section 10.37(a)(2) of Treasury Department Circular 230.

© 2025 KPMG LLP, a Delaware limited liability partnership and a member firm of the KPMG global organization of independent member firms affiliated with KPMG International Limited, a private English company limited by guarantee. All rights reserved.

For more detail about the structure of the KPMG global organization please visit https://home.kpmg/governance.

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