The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
BioPharm International-03-15-2018
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.
Process validation is an extension of biologics development processes.
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.
Research suggests that working with a single contract partner can reduce development time and improve economics.
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
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