Chemistry, Manufacturing & Controls (CMC) Support Services for Drug Development

project management - Execution of CMC programs - technical support - regulatory cmc support

Quick Overview

CMC-Rx Consultancy specializes in the technical and operational management of CMC activities that lead to the authoring of robust regulatory submissions & technical files for Investigational (IND) and New Drug Applications (NDA), Clinical Trial Applications (CTA) and Investigational Medicinal Product Dossier (IMPD).

We collaborate with your internal scientific and technical teams, your CDMOs and your suppliers, providing project management oversight for all your CMC activities.

Is your organization developing small-molecule or peptide drugs but lacks core expertise in organic, physical and/or analytical chemistry? Get in touch with us asap!


CMC Project Management & Execution

With a strong background in chemistry and the manufacture of Active Pharmaceutical Ingredients, CMC-Rx Consultancy manages all CMC activities related to drug substance and drug product development for virtual biotech companies in need of chemistry expertise.


CMC Technical Support Services

Our technical support services cover a wide range, including the identification of impurities and degradation products, interpretation of NMR spectra, review of batch records, assessment of Potential Genotoxic Impurities, physico-chemical characterization of drug substance and drug products, review of analytical data, and authoring of summary reports.


CMC Regulatory Support

We author comprehensive Chemistry, Manufacturing & Controls sections (Module 3 of the Common Technical Document) of INDs.

We also assist our clients with the authoring of the CMC sections of Pre-IND meeting requests and meeting briefing books.
CMC-Rx Consultancy: Changing the World, One API at the Time
Don't Let CMC Oversights Derail Drug Development
New drug development is so challenging that it’s hard to blame manufacturers for seeking shortcuts. But one area that cannot be given short shrift is chemistry, manufacturing, and controls (CMC) strategy
CMC is the most underappreciated aspect of the whole drug development process, but it can make or break development
Smaller innovative companies do not always understand the importance of having a clear CMC strategy. Some small biotechs take the approach of 'Let's run as fast as we can with whatever works, and if there's a problem, we'll deal with it later.'

A. Shanley, Pharmaceutical Technology, Vol 42, 11, p 20,22-23, 56; 2018