Navigate risk and regulatory complexity


Rethink risk and compliance to drive strategy, capabilities and performance

Pharmaceutical and life sciences companies must consider a wide range of emerging risks as they adapt their business practices to changing regulatory compliance and market-driven pressures. Some of these include globalization, the advancement of technology and expanding stakeholder expectations. Risks are no longer confined to discrete areas and functions within organizations. From regulatory pressures to consumer demands for increased transparency, organizations are increasingly seeking total solutions. New information systems, strategies, and processes to manage compliance are rapidly evolving in response to these pressures.
 

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Craig Cleaver, PwC, US Pharma and Life Sciences Risk Assurance Leader, talks about managing risk in a resilient organization

How PwC can help

A pharmaceutical or life science company’s risk management program may not be keeping pace with its appetite for growth. Going beyond traditional strategies, PwC identifies ways in which risk management can actually improve your company’s bottom line.

How do we create comprehensive compliance plans that address governance and operations challenges? PwC performs thorough risk analyses; designs strategic plans that align business, medical and patient needs; and facilitates program implementation so that clients can achieve critical objectives. We also...

  • Develop regulatory governance strategies.
  • Establish methods for responding to constantly changing industry trends.
  • Satisfy mandates according to CIA and industry best practices.
  • Implement CIA-readiness programs and conduct mock IRO reviews.
  • Develop integrated risk strategies and frameworks across compliance, regulatory, financial, and technology risk landscape.
  • Utilize the best sales and marketing practices for mitigating compliance, regulatory, and other key risks.
  • Create a strategy for complying with ever-increasing state, federal and global transparency requirements.

 

  • Design and implement useful risk assessment and forecasting tools and compliance monitoring programs leveraging data analytics.
  • Produce remediation, training, monitoring and auditing programs to be managed by third parties.
  • Transform internal audit functions through sourcing alternatives to provide strategic and subject matter expertise as companies evaluate and manage risk

Our team is anchored by experts in technology, finance, regulations, cybersecurity and privacy, business processes and data analytics. We provide insight, advisory services and independent assurance that enable pharmaceutical and life sciences organizations like yours make informed decisions and create invaluable safeguards in a complex risk environment.

Read more about our approach to transforming risk to your advantage.

 

Insights

Contact us

Brian Riewerts
Principal, Pharmaceutical and Life Sciences Risk and Regulatory Leader, PwC US
Tel: + 1 (410) 659 3390
Email

Craig Cleaver
US Pharmaceutical and Life Sciences Risk Assurance Leader, PwC US
Tel: +1 (267) 330 2908
Email

David Wysocky
Principal, Pharmaceutical and Life Sciences Transparency Leader, PwC US
Tel: +1 (973) 641 2040
Email

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