In the complex regulatory environment of today’s pharmaceutical, biotech, medical device, and diagnostics industries, companies and their counsel face an increasing number of governance, risk management, and compliance and data privacy issues, most of which have the potential for significant financial, economic, and reputational impacts. Guidehouse helps life sciences organizations navigate and synthesize highly complex healthcare transactions, rules, regulations, data, documents, and business practices. Through efficient integration of skills, data management, and analysis, we can assist in the development and execution of governance, risk management, and compliance strategies.
Our Governance, Risk Management and Compliance (GRC) capabilities include:
- Comprehensive compliance program assessment and support
- Industry code reviews
- Compliance Assessment and Risk Evaluation (CARE) development and implementation
- Compliance auditing and monitoring
- Discrete issue compliance assessment
- Due diligence
- High-effectiveness training and building of compliance culture
- Contract/vendor compliance
- Global compliance program development and implementation
- Comprehensive data privacy and security assessments and program implementation support, including HIPAA and GDPR compliance
- Board-level compliance effectiveness certifications
- Interim compliance officer support services
- Global transparency assessments and implementation
- Third-party due diligence
Latest From Risk Management Compliance Data Privacy
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September 29, 2021 PodcastInterested in Joining the Digital Therapeutics Revolution? Here’s How
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June 20, 2020 InsightsManaging the Business and Legal Risks of Working with Third PartiesMedTech Strategist Article - Mark Farrar, Thomas Hauser, Guidehouse and Juliet Lui, The Red Flag Group
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February 5, 2020 InsightsThe Path to a Stable Reporting Culture for Life Sciences CompaniesPublished in Law 360
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August 1, 2019 InsightsHow to Build a Compliance Program That's Rightsized for Your OrganizationBy J. Mark Farrar, MSJ, CPA, CFE, CFF and Kelsey Mullady, CFE, Life Science Leader
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June 4, 2019 InsightsA Prosecutor's Guide to Evaluating a Compliance Program: What Should Your Board Be Asking?By Saul Helman, Mark Farrar, Johna Carufel, and Elizabeth Prinzi
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January 24, 2018 InsightsPhysician, Feed Thyself: New Jersey’s Restriction on Pharmaceutical PaymentsNew requirements represent material changes to common industry practices
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May 9, 2017 InsightsManaging Safety Data in Patient Support ProgrammesComplying with EU regulations on adverse event data in new medicine trials
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