The Chemistry, Manufacturing and Controls (CMC) process is at the heart of drug development, underlying every step from concept to market and beyond. Unless the CMC development process is undertaken diligently, problems can materialize at any stage of a product’s development: during clinical trials, in the preparation of a marketing application, once an application is submitted or even after the marketing application has been approved.
This is where Kendle excels, as our CMC experts are chemists, pharmacists and biochemists and are located in all major regions of the globe. They possess detailed knowledge of the region-specific requirements vital to ensure your dossier is accepted by a regulatory agency.