Compliance Services
Sharing globally focused regulatory expertise in an automated digital 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.
Compliance Services
Building a unified compliance platform to help mitigate regulatory risks.
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
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
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)
Corporate Headquarters
855-751-5527