Compliance solutions for the life sciences industry
Compliance challenges for the life sciences industry
Navigate regulatory change
Navigate, plan, and predict changes in the regulatory environment
Over the past several years, life sciences companies have faced mounting demands from many directions, including increasing regulatory requirements, nonstop technological advances, and intense pricing pressures. And the unprecedented events in recent years have only provided more reason to modernize compliance and elevate the ability to identify and respond to regulatory change to meet expectations within your companies and from external stakeholders.
Modernize risk management operations
Compliance organizations should leverage tech, automation, and data to boost efficiency and engagement. They are challenged with digitizing compliance to keep pace with the business, anticipate regulations, provide predictive insights, and automate workflows using new tools to improve how compliance engages with the business.
Modernize approaches to respond to regulatory changes and risk management by leveraging enabling technologies.
Elevate organizational value
Compliance organizations want a seat at the table to be recognized as leaders who can help guide front-end strategy to help maximize commercial opportunity—while at the same time upholding the company’s commitment to the highest ethics and operating within the guardrails of compliance. Therefore, compliance teams should understand their business beyond the risk landscape and bridge the space between commercial aims and risk management.
Elevate the value provided by compliance and risk management activities across the organization.
Learn more about our life sciences compliance
solutions here.
What are your company’s biggest risks?
● Clinical trial registries and results databases
● Investigator-initiated studies
● Research grants
● Real-world evidence/reliance on outcomes research
● Clinical research organizations
● Hub and specialty pharmacy relationships
● Third-party service fees and fair market value (FMV)
● Field reimbursement activities
● Samples, co-pay cards, vouchers
● Pricing and contracting: government pricing and reporting and value-based contracting
● Direct-to-patient marketing and education
● Patient advisory groups interactions
● Patient assistance programs/patient support programs
● Samples, co-pay cards, vouchers
● Patient advocacy groups
● Aging IT Infrastructure and systems
● Data privacy
● Cybersecurity
● Electronic communications monitoring
● Social media
● Records retention
● Medical advisory boards
● Medical education grants
● Medical information requests
● Medical science liaison activities/proactive vs. reactive
● Off-label medical communications
● Globalization of the medical science liaison role
● Interactions with health care professionals (HCPs) including FMV bona fide fee-for-service payments
● Joint HCP interactions with commercial and medical affairs
● Joint payer interactions with commercial and market access
● HCP utilization and programs
● Promotional material review and dissemination
How Deloitte Life Sciences Compliance Advisory services create value
The Deloitte difference
Our compliance professionals work across all segments of the life sciences industry, including pharmaceuticals (pharma), medical technology (MedTech), and biotechnology (biotech). Our deep regulatory, compliance, and operations knowledge and technical skills and capabilities, coupled with our demonstrated life sciences experience, make us well-suited to serve you.
Learn more about our related services
The Deloitte US firms serve...
90% of the Fortune 500 life sciences companies.
Nearly 95% of the medical device manufacturers.
The top 12 largest pharma companies.
The top 10 largest biotech companies.
Dozens of emerging growth and rare disease companies.
