To produce a pharmaceutical dosage form, manufacturing processes, product characteristics, and product testing must be specifically defined to ensure that the product is safe, effective, and of consistent quality. We appreciate that successful delineation of these chemistry, manufacturing, and control (CMC) activities is a crucial part of the product-development lifecycle. Our integrated services across drug substance, particle engineering and drug product incorporates the appropriate CMC activities to satisfy global regulatory authorities.
In close collaboration with you, our Regulatory Affairs team will write a CMC dossier suitable to the stage of clinical development of your product manufactured by Lonza. This team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.