 |
FDA and government requirements such as 21 CFR Part 11, Sarbanes-Oxley, and GxP, as well as electronic submissions and contract pricing are becoming even more stringent. But beyond compliance, you need proven bottom-line results. Our regulatory planning and remediation solutions can help you identify root causes and implement programs that will increase Right First Time percentages, facilitate successful regulatory submissions, prepare for internal audits and assist with 483s, warning letters, and consent decree challenges. We can help:
- Increased end-to-end quality control throughout the entire manufacturing process
- Improved profitability and investor confidence with less FDA sanction and product recall risks
- Implement consistent and repeatable compliance programs applicable to any regulation or operating standard
- Enable effective integration of technologies and business processes supporting regulatory activity
Clarkston delivers:
- Strategy
- Program Management Office (PMO) and Compliance Program Office (CPO)
- Governance, Risk and Compliance (GRC) integrated solutions
- Industry benchmarking
- Roadmap development
- Organizational effectiveness
- Change management programs
- Audits, gap/risk assessments and action plans
- Process Development
- Process reengineering
- Validation mapping and execution
- Enabling Technologies
- Quality systems vendor review and selection
- Quality systems implementation
- Turnkey eCTD solutions (including vendor assessment/selection, strategic planning, business process redesign and project management)
- Systems Validation
- Training and Change Management
- Instructional development
- Training programs
From working on your standard operating procedures and control management to getting your manufacturing facility back in compliance, we can help. To learn more about our services, contact us at 1-800-652-4274 or via marketing@clarkstonconsulting.com.
|
|
