Projects can usually be classified in one of three categories:
1) A process is provided by a client under a Confidentiality Disclosure Agreement (CDA) and no process changes are allowed or expected. This is common for those products prepared under cGMP protocols when using master batch records ;
2) A product is required and some previous work has been done by the client, yet it is clear for economic or technical reasons that process development work is required as part of the project ;
3) A final target
molecule is indicated along with final specifications but no process has been
established. Our chemists then prepare a quotation based upon literature precedent,
cost of materials, and specific equipment & labor requirements. Depending
upon the structure of the contract, Narchem Corporation is prepared to submit
Premanufacturing Notifications, Drug Master Files, and Patent applications.
We will then work with the client to promote the success of all these processes.