Pre-approval inspections are conducted by the FDA as a part of its regular review of all product applications. MarketReady aims to provide guidance to manufacturers in all key milestones including product development, process validation and regulatory inspection.
Quintiles said the program also helps manufacturers manage issues that may result from prior regulatory actions associated with practices in laboratory and production settings.
Delays in product launch can mean losses in revenue and market share, said Joseph Phillips, vice president, Pharmaceutical Services, Quintiles Consulting, in a media release.
With MarketReady, our experts assist manufacturers in assessing, developing and implementing processes. This service helps assure an effective transition from R&D to commercial production.
