Compliance services
Clinical R&D
MFG
Risk-Based
Compliance
Commercial
Sales
& Marketing
Government Programs
Contracts
CalcPartner
& ClaimsPartner
Assessment &
Audit
COT & PHS
Validation
PCX
Features
CalcPartner –
a service to conduct and preserve Government Pricing Calculations
PharmaComplianceXchange (PCX)
|
Balancing Conformance across the organization.
In today's ever-changing regulatory
environment, pharmaceutical companies must establish a "Culture of
Compliance" – which is attained when compliance is integrated
throughout
the organization.
Our deep experience across the clinical, manufacturing and commercial
compliance
spectrum and our
industry relationships allow us to have a different perspective. When
it comes to helping you manage your specific risks and issues, our
approach allows us to develop and implement compliance best practices.
|
global
clinical services
- Business Process Analysis & SOPs
- Inspection Readiness (FDA, EMA, ICH)
- GCP Compliance Benchmarking & KPIs
- Drug Safety/Pharmacovigilance Strategy &
Implementation
- Compliance Training
Global Manufacturing services
- Internal/Supplier Audits
- cGMP Training
- Development of KPIs
- Start-up Activities
- Development & Enhancement of Quality Systems
- Root Cause Analysis & CAPA Effectiveness
- System Validation Documentation Review
- Regulatory Filings
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u.s.
commercial services
- Compliance Program Development & Maintenance
- State Compliance & Reporting
- Business Assessment & Profiling
- Policy & Procedures
- Auditing & Monitoring
- Risk Mitigation/Implementation
- Investigation/Litigation Support
- System Implementation & Validation
- Supplemental Resourcing
- Vendor Compliance
- Training
U.s. Government programs services
- Statutory Pricing Calculations
- Assessments & Audits
- Claims & Dispute Resolution
- CalcPartner
- ClaimsPartner
- COT & PHS Validation
- Federal & State Contracts
- TRICARE
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