Project Initiation_

Typically discussions start after signature of a CDA; dependent on the nature of the work, the client might then supply simply a target structure, a literature/patent prep, a MedChem prep or a detailed technical package. The deliverable might be the process, or a defined quantity of material, possibly made to cGMP. A variety of different contract types might be used: fee-for-service (FTE), fixed price, or a mixture of both. For GMP work, an MSA (Master Service Agreement) is usually established first, followed by individual work orders and quality agreements as appropriate.

Project Management_

Project teams are established at the outset. For early stage projects, this will typically comprise a process research chemist, process development chemist, analyst and a technician. The nominated project manager will report directly to the client. As scale increases the team will include the chemist managing production. For GMP work, project teams will also include QA representatives and representatives from the client’s team.

Reporting requirements vary, but typically comprise weekly telecons and written updates, in a form dictated by the client.