Develop your Chemistry Manufacturing, Controls and beyond Strategy and Roadmap

CMC experts initiate their work from early stages of development and become increasingly central and key functions as the product matures.
Our CMC experts know how to define your strategy and roadmap, find creative approaches to overcome challenges, and assist you with the required implementation.
CMCEarly StagePre-clinicalClinicalRegistrationMarket
Define CMC strategy and roadmap
Lead and support CMC gap assessments
Lead and support: process development (&trouble shooting), process scale up, tech transfer, process risk assessments, comparability exercises, process characterization and process validation
Contract Manufacturing Organization (CMO) selection and supervision including Person in Plant
Project management and coordination activities
Writing and reviewing Module 3 for IND and IMPD submissions
Support with analytical method development and validation
Provide ongoing CMC support remotely and/or at client’s offices (including master and executed batch records review, etc.)
Lead and support CMC inspection readiness and risk assessment processes
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