Compliance services
Clinical R&D
MFG
Risk-Based
Compliance
Commercial
Sales
& Marketing
Government Programs
Contracts
CalcPartner
& ClaimsPartner
Assessment &
Audit
COT & PHS
Validation
PCX
Features
Drug companies that do not have a
Compliance Program in place, may soon pay a very high price. Download
the white paper, Building
a
Compliance
Program.
PCX
–SALES & MARKETING
PCX –
Government Programs
|
THE Compliance roadmap.
CIS
helps companies evaluate their
current level of Commercial Compliance and develop a practical and
meaningful Compliance Roadmap, identifying gaps and priorities, and
developing a Compliance Program over time. CIS' experts have
thorough knowledge and understanding of the OIG regulations and
guidelines, FDA, False Claims Act, as well as industry practices and
related state laws and regulations.
| Commercial
compliance program |
Description |
| COMPLIANCE
ASSESSMENT |
Conduct objective,
third-party
assessment of US Commercial Operations including: corporate compliance
infrastructure, operational policy and procedure gap analysis, training
programs, monitoring and auditing. |
| COMPLIANCE ROADMAP
AND IMPLEMENTATION |
Build and assist in the
identification of what a Corporate Compliance Program should "look
like" for your organization and communicate the Program to the
organization. Establish a long term compliance strategy to build a
practical, effective and meaningful program. |
| POLICY AND PROCEDURE DEVELOPMENT |
Develop and implement Corporate Risk
Management policies and procedures related to Commercial Compliance.
Key components of the Corporate level policies include: Code of
Conduct,
Compliance Committed Charter, risk definition, compliance training,
evaluation, reporting, investigation and mitigation. |
| TRAINING |
Develop and implement training
programs specific to the roles and requirements of each aspect of a
Commercial Compliance Program. |
| ONGOING AUDITING AND
MONITORING |
Ongoing plan to
detect potential compliance risks, and to address or mitigate
compliance risks with corrective or disciplinary actions. Monitor
company's level of "audit readiness". |
"culture of
compliance lifecycle"
CIS' mission is to ensure that every aspect of your
Corporate Compliance Program is in compliance with the laws,
regulations and guidance directly related to ethical standards of your
business activities.
|
