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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES


Development & Technical Operations are the resources and processes affecting:

· Product Quality
· Product Cost
· Speed to Market

Our Insight …
SpyGlass has developed a roadmap for a comprehensive review, which focuses efforts on the critical issues not the trivial, to quickly uncover root causes of problems and opportunities for enhancing compliance and productivity.

SpyGlass assistance operates at the intersection of engineering, science and business. We use interdisciplinary teams, whose skills provide a multi-perspective approach:

SpyGlass action plans enhance key business drivers:

- timelines (schedule streamlining vs. slippage)
- costs (savings vs. overruns or inefficiencies)
- quality (consistent product integrity vs. probable recalls)

 

Our Services…

· Create a Development Plan
· Locate, qualify and manage suppliers and contract facilities
· Fill gaps in your expertise
· Provide an objective opinion
· Provide extra help during workload peaks
· Conduct training for inexperienced staff
· Troubleshoot/problem solve
· Scale-up/tech transfer to production facility
· Create a Validation Plan
· Ensure supply chain is efficient
· Prepare for FDA Submission and Responses
· Prepare for product launches and growth