Pharmaceutical CMC consulting
I spent nearly five years in pharma development - from formulation design through commercial manufacturing. I was the lead scientist on an FDA-approved NDA.
The challenge
Getting a drug product from formulation to commercial manufacturing requires thousands of decisions documented to FDA standards. Process descriptions need to accurately reflect what happens on the floor. In-process controls need to be scientifically justified. Tech transfers need to produce batch records that production teams can actually follow. And the CMC sections of your filing need to tell a coherent story that connects all of it.
Why me
At DPT Laboratories, I owned the full development lifecycle for pharmaceutical drug products under cGMP. I was the lead scientist on Ermeza (levothyroxine oral solution) from formulation through commercialization - I designed the manufacturing process, executed validation campaigns, managed stability programs, wrote the CMC sections, and supported FDA filing. The product launched successfully.
That means when I write CMC content, it's technically accurate because I understand the manufacturing process, not just the regulatory template. I've also done formulation design, process development, scale-up, packaging engineering, and tech transfer to plant operations.
How I help
CMC authoring
Module 3 sections for NDA, ANDA, BLA, IND. Process descriptions, in-process controls, manufacturing narratives.
Formulation & process development
Support for formulation design, process optimization, and development documentation.
Scale-up & tech transfer
Moving processes from development to commercial manufacturing. Batch records, validation protocols, transfer reports.
Stability programs
Protocol design, data trending, and stability summary writing for regulatory submissions.
Package engineering
Container closure qualification, component testing, and packaging documentation for filings.