THE BUSINESS CHALLENGE
Remediation isn’t just a compliance challenge – its effectiveness will make or break your bottom line.
It happened. An audit or inspection revealed less-than-stellar gaps in your compliance program and now you’re left putting the pieces together to get a full view at what went wrong, where, and why. This non-compliance isn’t just impacting your department, it effects revenue and profitability, production, market entry, and so much more. A one-off solution won’t fix this – you need a holistic and proactive remediation program.
Clarkston’s deep remediation experience ensures effective tailored solutions that identify, quantify, and prioritize regulatory risks.
An effective plan for identifying, addressing, and communicating non-compliance and remediation minimizes impact to your business and your brand.
- Root Cause Analysis and Internal Quality Audit
- Organizational Effectiveness
- Regulatory Communications Strategy
Successful remediation institutes practices that reduce time and effort but increase overall productivity and compliance.
- Process Improvement
- Change Management
- Program Management
Remediation projects are bolstered through an assessment of your IT infrastructure and a plan for submitting data to the appropriate stakeholders.
- System/Data Analysis and Augmentation
- Validation Services
- Submission Guidelines
What Our Clients Say
Senior Director Quality
The people I have worked with at Clarkston understand the business and technical needs of the Pharma industry. They think about what is needed long-term and broadly – not limited to the short term project.
We joined a remediation project for an international generics manufacturer dealing with gaps in marketing compliance. The project, three weeks underway and just 27% complete, was resulting in ceased shipments and $20 million in lost revenue each week. Within two weeks, we were able to meet regulatory commitments and accelerate the organization to a better compliance position. For more information on how we can help your company, please contact, Nicole Taylor.