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Case Studies

Overview:

  1. Rapid CMC and Clinical Development Review to Support a Complex Go / No-Go Decision
  2. Integrate Diverse Functional Expertise for Drug Development Plans with Reduced Risk and Rapid Time-to-Market
  3. Making Difficult Capital Expansion Decisions While Faced with Conflicting Input
  4. Taking Formulation Off the Critical Path to Get Into Man On-Time
  5. Complex Outsourcing Contract
  6. Interpret Complex Toxicology and CMC Risks in Order to Move Forward
  7. An Audit that Accomplished Quality, Regulatory AND Team-Building Objectives
  8. Address Critical Manufacturing Issues for a Complex Biologic
  9. High Powered Expert Panel Preserved and Created Value on a Deal- Breaker Issue
  10. Complex Package/ Shipping Validation Issue to Launch Key Products
  11. Manufacturing Strategy and Management Process Improvement
  12. Other Recent Projects
Please select a case study to find out more about how we have helped our clients.