Life Sciences and Healthcare Consulting Group

Our Consulting Group

Our first-of-its-kind consulting group has deep experience working both independently and arm-in-arm with our top-tier legal colleagues to design, build, implement, and operate effective compliance risk management programs—as well as the organizational constructs and resource models that support those programs across the enterprise.

Whether the context in which we work together is reactive (i.e., an investigation or government action) or proactive (i.e., borne out of a desire to enhance your risk management program or de-risk a transaction), we have the experience necessary to tailor our approach to your unique needs.

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“The work of this group is very much complementary to the traditional legal work of Paul Hastings’ life sciences law practice.”

The Practice, Center on the Legal Profession – Harvard Law School

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We Deliver Best-in-Class Consulting Services to Our Clients. And We Partner with Our Top-Tier Legal Colleagues to Provide Our Clients with a Holistic Approach to Complex Projects.

Our one-stop-shop enables us to partner with clients and advise on their business and legal objectives. We deliver tailored solutions, innovative value-added offerings, and seamless service across practices and regions. Our services include the design, implementation, assessment, and enhancement of the following:

• Risk Assessment Design and Execution – both Compliance Risk Assessment and Enterprise Risk Management (ERM);

• Methods for determining the Fair Market Value (FMV) of payments to HCPs, patients, and third-party service providers (including those in the distribution channel, e.g., PBMs, GPOs, and wholesalers), royalty streams, milestone payments, and clinical trial-related payments;

• Compliance Program Governance, Resourcing, and Operations;

• Written Standards (policies, procedures, work instructions, etc.);

• Compliance Training and Communications; and

• Compliance Auditing and Monitoring Programs.

We work to understand your unique needs and context, and tailor our experience and solutions to meet those needs. We collaborate with you to assess factors like geographic and functional scope, therapeutic/clinical service areas, company culture, risk management and compliance operations, risk domains and interactions, and your unique compliance context to identify the best ways in which to meet your needs.

Life Sciences Company Context Assessment

We always start by understanding your unique needs and context, and tailor our experience and solutions to meet those needs.

 

Healthcare Company Context Assessment