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Features
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Compliance Is Our First
Name.
Compliance Implementation Services (CIS)
is a consulting firm specializing in compliance strategies for
pharmaceutical companies, from Global Clinical Research &
Development through Manufacturing, U.S. Commercial Compliance and
Government Programs. Founded in 2004, our clients rely on our deep
understanding of industry laws and regulations, innovative and
practical applications and custom solutions to establish a "Culture of
Compliance" that is both meaningful and sustainable.
Our experts identify, assess and prioritize your organization's
exposure to compliance risks, subsequently developing and implementing
risk evaluation and mitigation techniques to ensure adherence to legal
and regulatory requirements.
Compliance solutions that span across the entire
product lifecycle
compliance
Knowledge
and
expertise
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CLINICAL
R&D
- Good Clinical Practice (GCP)
- FDA Regulations
- FDAAA
- EU Clinical Trial Directive
- EMA Guidance
- ICH
- OIG Compliance
Manufacturing
- cGMP
- FDA Regulations
- ICH Q Topics
- EU Regulations
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COMMERCIAL
Sales & Marketing
- OIG Compliance
- Federal & State False Claims Act
- Federal Anti-Kickback Statute
- HIPAA
- PhRMA Code
- PDMA
- FCPA
- State Compliance & Reporting Laws
GOVERNMENT
PROGRAMS
- OIG Compliance & Audit Readiness
- Medicaid Drug Rebate Program
- VA & Federal Contracting
- State Programs
- Medicare Parts B & D
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