CMC consulting & regulatory writing
I've authored CMC sections that supported a successful FDA-approved NDA. I know what reviewers want to see because I've been through the process.
The problem
Your filing deadline is approaching and the CMC sections aren't written - or they're written but not at the quality FDA expects. Process descriptions are vague. Manufacturing narratives don't match what actually happens on the floor. In-process controls aren't clearly defined. The regulatory team is asking manufacturing for information that doesn't exist in a usable format.
My approach
I spent nearly five years at DPT Laboratories doing pharmaceutical development from formulation through commercial manufacturing. I was the lead scientist on Ermeza (levothyroxine oral solution) and authored the CMC sections that supported its successful NDA approval. I know what goes into Module 3 because I've built it from the bench up - process descriptions, in-process controls, manufacturing flow narratives, batch analysis, stability data presentation, and container closure documentation.
I write CMC content that's technically accurate because I understand the manufacturing process, not just the regulatory template. That means fewer review cycles, fewer questions from the agency, and a filing that holds up under scrutiny.
What I deliver
Module 3 CMC authoring
Process descriptions, in-process controls, manufacturing narratives, and batch analysis for IND, NDA, ANDA, and BLA submissions.
Process development reports
Documentation of development history, formulation rationale, and process optimization that supports the CMC story.
Manufacturing flow narratives
Clear descriptions connecting raw materials through finished product that match what actually happens in the facility.
Stability program support
Protocol design, data trending, and stability summary writing for regulatory submissions.
Tech transfer documentation
Batch records, process parameters, validation protocols, and technology transfer reports supporting site transfers.
Container closure documentation
Package engineering, component qualification, and container closure system descriptions for regulatory filings.
Who this is for
Pharma and biotech companies preparing NDA, ANDA, BLA, or IND submissions with CMC gaps. Companies needing experienced CMC writers who understand manufacturing, not just templates. Programs doing site transfers that need tech transfer documentation.