Besides formulation development, Kinesis’ department of Chemistry, Manufacturing & Control (CMC) can assist you with an extensive range of activities related to chemical pharmaceutical development, including analytical development and stability studies.

We can do the following for your project:

• Selection of API producers and CMO for chemical pharmaceutical activities, like fill and finish, and storage and distribution of CTM.
• Advice on development of upstream and downstream processing and biological formulation development
• Writing of chemical pharmaceutical related regulatory documentation, like an IMPD, IND, CTD module 3, DMF / BMF, GMO risk assessment reports and viral safety expert reports.

We can also assist you with GMP implementation and QP release.

  Case studies