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Life sciences compliance and ethics solutions

Identify risks, build governance, and design processes through your life sciences compliance program

Compliance departments in life sciences organizations are challenged with maintaining regulatory and ethical obligations while empowering the business to achieve strategic goals. Learn how our advisors can help develop solutions specific to your company’s needs.

Embracing risk

Risk has traditionally been viewed as something to be minimized or avoided. But we believe that risk can also be a creator of value and—when approached in an effective way—can play a strong role in driving business performance.

Today’s life sciences and health care organizations operate in an environment that is increasingly regulated and scrutinized. They’re challenged with pricing pressures from government agencies and politicians; the rapid adoption of social, mobile, and cloud-based technologies; increased competition; and the changing demographics of patients and payers.

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Anticipating challenges

Leading organizations anticipate these challenges and recognize the opportunity to create value through risk management. We have the regulatory knowledge, deep industry experience, and problem-solving culture to help you anticipate the changing life sciences landscape and navigate complex regulations and commercial challenges. We collaborate with you to identify potential risk areas and help build governance and processes to increase efficiency and gain business insight.

Our services include:

  • Compliance program design and implementation: Maintain compliance obligations while empowering the business to achieve strategic goals.
  • Compliance audits and risk assessments: Reduce risk and achieve greater efficiency.
  • Fair market value (FMV) for health care providers (HCPs): Simplify the FMV process for greater compliance and business insight.
  • Regulated content management: Accommodate a dynamic regulatory environment with efficient and compliant solutions.
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Fair market value (FMV) for health care providers (HCPs)

Regulators expect you to have clearly documented methodologies for FMV and to apply those methodologies consistently around the world. We provide a consistent and streamlined methodology that satisfies government and market expectations when contracting with HCPs who perform services such as advisory boards, speaker training programs, and ad-hoc consulting services.

We provide a 360-degree view of FMV compliance that includes:
  • Policies and processes that demonstrate a need for the activity
  • Contracting guidelines that reflect regulatory safeguards and a defensible FMV framework
  • Periodic monitoring of adherence to processes, deliverables, and payment guidelines
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Regulated content management

​Drug and device manufacturers are increasingly looking for ways to enhance the timeliness and impact of the marketing and promotion of their products. With the proliferation of new communication channels, a shift in how companies deliver information to their customers, and ever-increasing regulatory scrutiny, a continuous focus on improving the development, review, approval dissemination, and management of such content becomes even more critical.

Deloitte has assisted life sciences companies in developing industry-leading content-management strategies through improvement of processes and technologies throughout the stages of the content management lifecycle.

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Get in touch

Paul Silver

Paul Silver

Principal | Life Sciences

Paul is the Deloitte Risk and Financial Advisory’s Life Sciences Regulatory and Compliance leader for Deloitte & Touche LLP. He has 30 years of experience in the pharmaceutical, medical device, and co... More