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


"The trend of outsourcing manufacturing continues as a viable business strategy. Whether your company is a Fortune 100 multinational or a small medical device start up, market pressures on cost, time to market or shifts in technology continue to support outsourcing."

Our Insight
SpyGlass has seasoned professionals who have first hand experience starting up and managing manufacturing outsourcing relationships, in both the consumer products and medical device markets. We know what it takes to make these relationships work and, more importantly, what pitfalls to avoid. As more and more government agency oversight is placed on these products, we know what systems are required to prevent the dreaded product recall.

If you are looking to outsource, SpyGlass can provide the following:

Help you identify the key drivers in the decision process.
  o Free up internal resources
  o Access to state of the art technology
  o Enhance time to market
  o Improve focus
  o Reduce/control cost

Guide the selection process by choosing the right partner.
  o Technology Assessment
  o Quality System readiness
  o Resource availability
  o Relationship Management
  o Current track record

Help structure the internal resources to manage the outsourcing relationship.

Provide templates for Supply and Service Level Agreements.

Provide frame work for ongoing monitoring.

If you are a provider of Manufacturing Outsource services, SpyGlass can provide the following:

Insight into challenges in supporting large established companies as well as small start ups.

Evaluate your current or proposed quality system for compliance.

Review the elements of a flexible manageable Supply and Service Agreement.

  o Capital Investments
  o Equipment Ownership
  o Inventory Management
  o Buffer Capacity
  o Cost and Price escalators and de-escalators.

Provide guidance on a Relationship Management Process.

  o Structure
  o Monitoring Scorecard
  o Product & Process Improvements
  o Management Reviews

When and how to say no to a product transfer opportunity.