• Welcome to

    Document Quality (CMC)!

  • Shop for Chemistry, Manufacturing, and Controls templates to aid in writing your next US FDA drug application! Contact me concerning consultant work. I can even help you if you're stuck narrating your pharmaceutical development work.

    When you have to make sure, make sure it's Document Quality (CMC)!

  • Topics Within My Writing Scope

    I have experience writing Module 2 (Quality Overall Summaries for the drug substance and the drug product), and Module 3 (Section 3.2.S Drug Substance and Section 3.2.P Drug Product). Based on Sponsor data and product specific background information supplied to me, I am able to write Pharmaceutical Quality sections for INDs, NDAs, and ANDAs. 
    Additionally, if you need a consultant to review your responses to FDA-generated Information Requests (based on deficiencies in the Pharmaceutical Quality sections of your application), I am available to assist you. 

  • Topics Out of My Writing Scope

    Please note: I do not write BLAs, provide Facility Inspection advice, or any advice on vendors (API, excipients, laboratories, manufacturers, etc.).
    Additionally, I do not submit CMC/ Pharmaceutical Quality files directly to the FDA. You shall receive Microsoft Word files that can be saved as PDFs according to your purchase selection for use in your IND, NDA, or ANDA.