Compliance Services

Sharing globally focused regulatory expertise in an automated digital platform

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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.

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Government agencies enforce complex regulatory environments, creating disjointed enterprise-wide views of compliance risks.

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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.

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REMS / RMP Solutions

  • REMS / RMP automated digital solutions

  • Complex multi-sponsor automated programs

  • Patient, product, prescriber and pharmacy focused

  • Full digital automation cloud-based platform

  • Configurable workflow management

  • Program tracking and reporting capabilities

  • Governance and compliance controls

  • Medical affairs support and collaboration 

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Adherence and Governance

  • SOP development

  • Full SDLC adherence

  • Complete test plan execution

  • CAPA Quality Management

  • Quality management & assurance

  • System validation readiness

  • 21 CRR Part-11 validation

  • HITECH / HITRUST Adherence

  • PII, PHI & HIPAA Compliance

  • GDPR and GxP regulatory focus

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Compliance Excellence

  • Project Management Office (PMO)

  • Quality, compliance and risk focus

  • Documentation lifecycle governance

  • Regulatory event/incident management

  • Onsite and virtual audit readiness

  • Automate compliance system

  • Corporate learning and information management systems (LIMS)

Contact Us

Learn more about our ability to innovate and deliver measurable value.

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Corporate Headquarters

855-751-5527