Project Briefs

Tunnell has been involved in thousands of successful projects. Here is a sampling of the accomplishments many companies have been able to achieve using our proven methodologies and best practices.

PAI Readiness For Seven ANDA Products

  • PAI Support
The company’s financial success was dependent on placing these drug products into the market place as soon as possible.

PAI Preparation and Readiness

  • PAI Support
For a successful outcome, it was instrumental to not only identify problems but to identify and implement corrective actions to resolve the underlying problems.

New Facility Preparation for Pre-Approval Inspection

  • PAI Support
A culture of continuous improvement and optimization was achieved along with a definitive understanding what it means to be “inspection ready” at all times.

Bio-Facility Qualification, Start-Up & Licensure

  • PAI Support
A Tunnell ‘core’ team of functional area SMEs conducted a rapid risk assessment and developed a detailed implementation plan for the qualification, start up

Analytical Method Validation PAI Readiness / Certification

  • PAI Support
The manufacturer had been cited on several 483’s for inadequate analytical method validation.

Microbiology Lab Remediation and Process Improvement

  • Biotech Support
Results led to marked improvement in throughput and a significant decrease in investigations.

Compliance Remediation

  • Quality, Regulatory, Compliance
Over 8500 SOPS reviewed and revised; approximately 125 SOPs eliminated or streamlined.

Lean Lab and Cost Reduction

  • LEAN SIX-SIGMA / BUSINESS TRANSFORMATION
Throughput time dropped from 15 days to 8, an improvement of 53 percent.

Manufacturing Capacity Increase via Cycle Time Reduction

  • Turnkey Solutions
The client learned how to reduce cycle time without a significant investment.

Manufacturing Process Reliability: Reducing Process Interruptions

  • MANUFACTURING PROCESS IMPROVEMENT
Savings from reduced product loss totaled $850K over a 6-month period.

Product Launch Capacity Planning and Modeling for Improved Probability of Success

  • MANUFACTURING PROCESS IMPROVEMENT
After the project a sense of urgency was sustained.

Technical Transfer / Consent Decree Remediation

  • Technical Expertise
Successful product launch with projected $59M sales forecast.
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