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As FDA and government requirements such as 21 CFR Part 11, Sarbanes-Oxley, GxP and contract pricing become more stringent, effective compliance programs are the key to successful product launches and increased revenue. Our regulatory planning and remediation solution helps pharmaceutical companies identify root causes and implement programs that will increase Right First Time percentages, prepare for internal audits and assist with 483s, warning letters, and consent decree challenges. Clarkston Consulting's regulatory and remediation team can help your company achieve:
- Increased end-to-end quality control throughout the entire manufacturing process
- Improved profitability and investor confidence with less FDA sanction and product recall risks
- FDA's operating paradigm that demands a higher level of enterprise wide consistency across quality systems infrastructure
- Consistent and repeatable compliance programs applicable to any regulation or operating standard
Clarkston delivers:
- Strategy
- Program Management Office (PMO) and Compliance Program Office (CPO)
- Governance, Risk and Compliance (GRC) integrated solutions
- Industry Benchmarking
- Road Map 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
- Systems Validation
- Training
- Instructional Development
- Training Programs
From working on your standard operating procedures and control management to getting your manufacturing facility back in compliance, Clarkston's Planning and Remediation solution will implement industry best practices along with a customized approach to your environment and specific challenges. To learn more about our services, call us toll free at 1-800-652-4274 or send an email to marketing@clarkstonconsulting.com.
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