Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.
For decision making and overall program risk reduction, a quality-risk-management (QRM) program is an effective means for biotech companies to mitigate the risks associated with outsourcing crucial elements of the drug-development lifecycle. Risks only get larger when activities typically performed internally during the development process are outsourced to a contract service provider.
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BioPharm International’s 2015 Outsourcing Resources eBook.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.