Manufacturing Process
Analytical Assays
Product characterization & specs definition
Preclinical experiments (in vitro & in vivo)
Pivotal preclinical efficacy and toxicity
IP creation and follow up
Project plan preparation
Budgeting
Coordination (internal and external)
Delivery in time
Process optimization
In process controls & specifications
Scale up
Tech, Transfer
R&D support
Quality documents management
Process & anal. assay qualification
Regulatory strategy
New projects screening
In- and out licensing
Collaboration agreements
Tech Transfer agreements