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CMC

We now have a number of CMC consultants need for assistance with the writing and compilation of the Drug Master File (DMF), Chemistry, Manufacturing and Control (CMC) sections of the Investigational New Drug (IND) requirementsFor the DMF can you provide a bit more detail on the role of the chemist in the writing?

  • What documentation is already available?
  • Is the need more for compilation/grammatical/formatting support or actual writing?
  • Can you give me some sense of what remains to be done to take this from draft to final for planning purposes?  For example,
  • Have the summaries and overviews been done as well? Kind of
  • Are they already in CTD format? ???
  • Do you have the IB done?  no
  • Are the clinical protocols ready? yes
  • Has a General Investigational Plan been developed? Kind of
  • Do you have the FDA Form 1572 prepared including the Investigator Information?

At the present time we understand that you may not need much assistance with the biology side of things since QR Pharma already has these sections of the IND in draft.  However, please note that we can also assist with any other document and compilation gaps and the progression of those sections into IND ready format if necessary.