Our successes include:
- Speedy and cost-effective development of several phase I, II, and III product programs to meet aggressive timelines, using both internal assets and managing CDMOs
- Identification and engagement of a CDMO to develop and commercially manufacture a high ethanol concentration companion animal product
- Successful negotiation with FDA to enable a path forward, despite chemical stability issues, for initiation of phase III studies of an oral liquid suspension
- Significant contributions to the development, approval and commercialization of thirteen drug products in the US, EU, and Japan
- Strategy development for a startup CDMO enabling fast growth in a competitive market
- Strategy development for a mid-size CDMO enabling technology diversification to protect market
- M&A and licensing due diligence enabling the acquisition of two ophthalmic and one GI pharmaceutical asset
Cordack 