About Ashutosh Pandit

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So far Ashutosh Pandit has created 4 blog entries.

Managing a Tech Transfer Redesign Post-Acquisition

By |2024-01-29T11:02:22-05:0001/29/2024|

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 redesign their TT processes to accommodate changes in technology, regulatory requirements, clinical strategies, or other similar reasons. However, even repurposing a manufacturing facility can drive a [...]

Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies

By |2022-06-30T16:04:53-04:0006/30/2022|

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 can be challenging for Finance to assess the upstream and downstream impacts of such changes. Similarly, strategic business changes [...]

CMC Project Plans: A Critical Tool for Early-Stage Biopharma

By |2022-01-25T10:42:30-05:0001/25/2022|

CMC Project Plans: A Critical Tool for Early-Stage Biopharma The Challenge for CMC Teams CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in [...]

Event Recap: Stage-Appropriate Quality Systems

By |2023-06-28T11:34:04-04:0010/22/2020|

Event Recap: Stage-Appropriate Quality Systems Ashutosh Pandit, Consultant & Todd Applebaum, Managing Director Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a [...]

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