Integrated across the product and the manufacturing network.
Drug Substance
Process development, scale-up, process characterization, technology transfer, control strategy, registration campaigns and commercial manufacturing.
Drug Product
Formulation, process development, scale-up, process optimization, registration manufacturing and lifecycle strategy.
Enabling technologies
Spray drying and technically complex intermediates for small-molecule products with formulation or bioavailability challenges.
Analytical and control strategy
Method lifecycle, qualification and validation strategy, specifications, impurities, stability and integrated product control.
CMC regulatory strategy
IND development, EOP2 preparation, pivotal-stage CMC strategy, NDA readiness, comparability and post-approval planning.
CDMO strategy and governance
Selection, due diligence, technology transfer, technical oversight, change control, issue escalation and executive governance.
Clinical supply
Demand planning, manufacturing, packaging and labeling strategy, IRT interfaces, distribution and supply-risk management.
Commercial readiness
Validation strategy, launch inventory, commercial manufacturing network, supply resilience and operating governance.
CMC organization leadership
Operating model, portfolio priorities, team build, external expert network, executive communication and decision governance.
