We assist companies in creating realistic and actionable CMC development plans for small-molecule and peptide drugs.
Starting with the creation of a Target Product Profile (TPP), we then define critical path activities, product requirements, costs and timelines for Drug Substance and Drug Product manufacture.
Acting as a liaison between CDMOs and our clients, we provide CMC oversight and support, and execute CMC Action Plans by organizing and leading weekly teleconferences, keeping track of project advancement, and providing weekly progress reports to our clients' management teams.
Complementing our Project Management services are our Technical CMC Support Services
This is our core business. We cover a vast area of CMC activities, including establishment of manufacturing routes, specifications and controls, assessment of manufacturing processes, troubleshooting, optimization & scale-up, risk analysis, planning and oversight of CTM manufacture, vendor selection and qualification, assistance with product and impurity characterization, monitoring of stability studies, analytical method development, and interpretation of analytical data. See also our Technical CMC Support Services.
Paperwork is important. The devil is always in the details. We make sure you start off on the right foot with your vendors. Avoid continuous or unnecessary scope changes, cost overruns and other surprises.
We do not offer any legal advice, but look at QA agreements, MSAs and Statements of Work from a CMC angle, ensuring that the agreements, project scopes and deliverables are all in agreement with the CMC Strategy.