CMC Regulatory Writing & Advise
How we can support
We have experience across various domains of CMC development which enables us to accommodate most projects. Our customers are located globally and we have supported projects of varying scopes, ranging from consultation on isolated questions to writing of eCTD module 3 Marketing Authorization Application for EMA and FDA. To provide a brief overview, here are typical CMC activities supported by the CMC Drug Product Consulting team:
Late stage CMC development
Project management of the module 3 writing process for phase 3 or commercial launch NDA/BLA/MAA
Authoring of module 3 sections including review of source documentation and data processing.
Authoring of module 2 Quality Overall Summary in NDA/BLA/MAA.
CMC gap analysis towards phase 3 and commercial
Strategic advice on hot topics such as justification of specifications, stability data package, process development and validation, control strategy for drug product critical quality attributes.
Early stage CMC development
Regulatory CMC writing of module 3 sections in IMPD and IND
CMC gap analysis towards phase 1/2 clinical trials
Coordination of writing activities with key knowledge holders such as R&D, production and QC.
Document tracking and follow up with authors
Strategic advice on process and product related challenges
