Compliance Services
Sharing globally focused regulatory expertise in an automated digital platform
We support our clients with solutions that deliver REMS / RMP automated digital solutions and multi-sponsor automated workflows, leveraging secure cloud-based platform.
Compliance Regulatory Challenges
In an increasingly regulated environment, Life Sciences companies face unprecedented scrutiny.
Vigilant compliance is demanded due to greater transparency expectations, more emphasis on technology, and a global marketplace.
Government agencies enforce complex regulatory environments, creating disjointed enterprise-wide views of compliance risks.
Reporting systems are dependent on complex legacy infrastructure, and result in resource intensive and time consuming processes.
Compliance Services
Building a unified compliance platform to help mitigate regulatory risks.
REMS / RMP Solutions
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REMS / RMP automated digital solutions
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Complex multi-sponsor automated programs
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Patient, product, prescriber and pharmacy focused
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Full digital automation cloud-based platform
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Configurable workflow management
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Program tracking and reporting capabilities
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Governance and compliance controls
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Medical affairs support and collaboration
Adherence and Governance
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SOP development
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Full SDLC adherence
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Complete test plan execution
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CAPA Quality Management
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Quality management & assurance
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System validation readiness
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21 CRR Part-11 validation
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HITECH / HITRUST Adherence
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PII, PHI & HIPAA Compliance
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GDPR and GxP regulatory focus
Compliance Excellence
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Project Management Office (PMO)
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Quality, compliance and risk focus
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Documentation lifecycle governance
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Regulatory event/incident management
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Onsite and virtual audit readiness
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Automate compliance system
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Corporate learning and information management systems (LIMS)
Contact Us
Learn more about our ability to innovate and deliver measurable value.
Corporate Headquarters
855-751-5527