We provide a full review and development planning service, including milestones for early synthesis testing and feasibility standards. We specialise in optimizing the discovery – development interface and assist on planning for phase dependent development plans.
Our clinical trial manufacturing services are produced in our cGMP compliant facilities supporting investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials around the world.
We offer our customers a fully integrated services including with raw material sourcing, supplier approvals and raw material characterisation, formulation development, pilot batch manufacturing, scale-up, pilot batch manufacturing, cleaning method development and full GMP validation and full-scale manufacturing for commercial support.
Our development team operate on a risk-based approach with full compliance to GMP requirements, this includes supporting projects with documentation and reports that will be used to support regulatory filings.
Ellen has a Master in Chemistry and has worked as a Research and Development Chemist within Magle Chemoswed since 2000.