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Expert Legal Support

Legal Services for Life Sciences Commercial Compliance

Our dedicated team of legal experts provides comprehensive, tailored solutions to navigate the intricacies of regulatory requirements in the life sciences industry. Deep knowledge, practical experience, and a commitment to helping your organization thrive.

Schedule a Demo

Our Legal Service Areas

Comprehensive legal support for every dimension of life sciences commercial compliance.

FDA & Regulatory Compliance
Assistance with navigating FDA regulations, including promotional practices, off-label communications, and marketing compliance.
Anti-Kickback & False Claims
Guidance on Anti-Kickback Statute (AKS) compliance, False Claims Act (FCA) exposure, and government investigation defense.
Sunshine Act Compliance
Legal interpretation and compliance support for CMS Open Payments obligations and state transparency laws.
HCP Engagement Legal Review
Legal review of HCP contracts, consulting agreements, speaker bureau programs, and advisory board structures.
Compliance Program Development
Legal framework development for compliance programs aligned with OIG guidelines and DOJ evaluation criteria.
Government Investigations
Support during government investigations, subpoenas, and voluntary self-disclosure processes.

Why Legal Expertise Matters in Life Sciences Compliance

The life sciences industry operates under one of the most complex regulatory frameworks in the world — with potential exposure under the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, and numerous state laws.

qordata's legal services team combines regulatory expertise with deep life sciences industry knowledge to provide practical, actionable guidance — not just theoretical risk analysis.

  • Compliance Program Design: Build legally defensible compliance programs aligned with OIG guidance and DOJ evaluation criteria.
  • Policy Development: Draft, review, and update compliance policies and SOPs for commercial activities.
  • Training Programs: Design and deliver legal compliance training tailored to field sales, marketing, and medical affairs teams.
  • Risk Assessments: Conduct legal risk assessments of commercial programs before launch.

Regulatory Areas Covered

  • Anti-Kickback Statute (AKS)
  • False Claims Act (FCA)
  • Physician Payments Sunshine Act
  • FDA promotional regulations
  • FCPA and international anti-bribery laws
  • State transparency and price laws
  • OIG compliance program guidelines

Talk to a Life Sciences Legal Expert

Connect with our legal team for tailored guidance on your compliance program and regulatory obligations.

Talk to an Expert
(609) 375-0010
sales@qordata.com
103 Carnegie Center Dr, Suite 300
Princeton, NJ 08540

Company

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Services

  • Compliance Program Setup
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  • Legal Services
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qordata Inc.
qordata Inc.