Regulatory Compliance Services

Omicron has over 10 years' experience in regulated industries providing regulatory compliance and technology solutions that mitigate risk and improve business performance. Omicron has successfully completed hundreds of projects centered on regulatory compliance and technology solutions in regulated environments. With knowledge of the systems and processes used in regulated industries, Omicron offers risk-based, compliance solutions that address applicable industry standards and government regulations, including FDA, GxPs, 21 CFR Part 11, EPA, DEP, NRC, EMA, FERC and Sarbanes-Oxley, as well as SEC, USHHS, and State DEP Agencies.

At the center of Omicron's Regulatory Compliance Services is our Regulatory Compliance Review. The Compliance Review relates the experience of our staff, methodology, projects and industry learning to deliver insightful review and recommendations to our clients. During a typical review, we:

• Review existing documentation associated with the area of review.
• Interview staff members in order to gather input to the process.
• Create assessments and recommendations associated with a given risk area
• Review assessments and risk mitigation and remediation strategy with the client.
• Update assessments based on discussions with team and client management.
• Publish findings for approval by the client

This flagship service can be used to help address areas such as:

• Regulatory Compliant Implementations
• Risk Analysis / Prioritization
• Systems Audits / Assessments
• Process and System Gap Analysis
• Quality Management Office / System Development
• System Lifecycle Development / Application
• System Documentation / Remediation
• Program Office Development, Deployment and Management

Omicron can develop solutions with open electronic formats, such as XML and BizTalk, which can automate collection, storage and sharing of scientific data. We can leverage our wide experience in Data Warehousing, EAI, Security and Internet technologies. Our solutions will address features like centralized data, single data entry, single sign-on and security by using technologies such as Digital certificates, EAI and LDAP.

For more information, please feel free to Contact Us.