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07 07 22 -- FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

12 09 21 -- Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry

10 19 21 -- COVID-19 Spurs Growth Of China s Domestic Bioprocessing Suppliers

07 15 21 -- Implementing DSCSA With New FDA Guidances

07 15 21 -- Implementing DSCSA With New FDA Guidances
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01 07 21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies

01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies     This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here. Featured Editorial By Herman F. Bozenhardt and Erich H. Bozenhardt Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality.

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