CMC Project Leadership & Management
We provide all types of chemistry, manufacturing, and analytical controls consulting, specializing in small molecules and antibody drug conjugates
CMC Due Diligence Support
We assess CMC readiness for IND and all clinical phases
IND, NDA, BLA Regulatory Filing Support
We author sections and provide input for global regulatory submissions/pre-meeting packages/approvals including module 3 of the common technical document
Expert Testimony
We provide technical and scientific support for patent infringement and related litigation from a chemistry, manufacturing, and analytical controls perspective