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About 70% of FDAReady's work is with CMOs
and virtual companies. In recent years, outsourcing
has boomed. Contract manufacturing certainly
decreases capital costs, but companies have generally underestimated the
level of involvement needed to make the relationship work. For
the contract-giver, there is a loss of control over operations. For the CMO, scheduling resources is critical. FDAReady Consulting has relationships with
the industry-leading biopharmaceutical CMOs. In some cases, the consulting arrangement
includes both parties simultaneously. A truly
neutral third party is often the key to breaking down barriers to success. The dialogue frequently begins by ending the destructive
contest of which party is more damaged by failure:
we plan for mutual success. FDAReady has worked with clients to
establish quality systems, inspection preparedness, and quality agreements
for both sides.
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FDAReady | Inspection Prep Strategy | Services | Clients | CMOs and Outsourcing | Qualifications | Partnerships | Contact |
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