888 Pharmaceutical is a Global Regulatory Affairs Consulting firm based in Boise, Idaho, specializing in providing comprehensive regulatory submission support for new and complex post-approval generic applications and new drug applications. With over 30 years of experience, they have successfully filed and supported new drug applications for both small generic pharmaceutical manufacturers and fortune 100 pharmaceutical manufacturers.
Their team of Regulatory Affairs and Quality Assurance experts excels in regulatory strategy, CMC Chemistry, Manufacturing, and Control, and Quality Assurance, with a distinct specialization in Generic Drugs, Complex Biologics, Tissue, Aseptic Manufacturing, and Sterile Fill Finish. They offer a wide range of services including product lifecycle management, regulatory project management, technical manufacturing support, supply chain support, process optimization, data analysis, quality assurance, and eCTD publishing.
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