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expert

Manage risk to stay ahead of competition

Leverage the expertise of those who have spent 25+ years navigating quality, safety, and compliance issues.

Regulatory compliance is non-negotiable, but it can also be a potent, forward-looking source of competitive advantage. With new regulations challenging quality and safety standards, turning to experts, who have been there and done that, can mean the difference between success and failure.

Expertise:

Providing specialized expertise to accelerate drug development and FDA approval.

  • GCP, GLP & GMP Quality
  • Clinical Data Integrity Reviews
  • Quality System Assessment & Remediation
  • Benefit/Risk Management (including REMS)

  • Pharmacovigilance (PhV) Auditing
  • Adverse Event Reviews
  • Regulatory Safety Reporting
  • Inspection Readiness Support & Remediation
  • Due Diligence
  • Audits & Remediation
  • Mock Regulatory Inspections
  • U.S./E.U. & Global Regulatory Strategy, Response & Execution

Solutions:

Deploying cross-functional expert teams to define and implement key strategies.

  • Stage-gate/Due Diligence
  • Patient Safety and Regulatory Compliance

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