Managing a Tech Transfer Redesign Post-Acquisition
Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally…
Perspective
CMC Project Plans: A Critical Tool for Early-Stage Biopharma
CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team…
Perspective
Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies
The CMC landscape is complex, uncertain, and dynamic, driving the CMC team to constantly adjust their plans and timelines. It…
Perspective
Event Recap: Stage-Appropriate Quality Systems
Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for…