Diteba and Thesis Chemistry have brought together their proven technical and regulatory expertise in process chemistry, cGMP fine chemical production and analytical testing to serve the pharmaceutical industry with timely Chemistry, Manufacturing and Control (CMC) services for rapidly advancing a small-molecule drug from concept to commercialization.
The molecular structures of drug molecules are becoming increasingly diverse as scientists improve upon potency, selectivity and safety. These demanding molecular structures require experience in a broad range of chemical processing and analytical technologies from a CMC partner. Furthermore, outsourcing is simplified when a drug innovator can rely upon the CMC partner to support their material supply requirements from pre-clinical to launch. Thesis Chemistry and Diteba Research Laboratories can satisfy your outsourcing needs in precisely these ways. We understand the ever-growing complexity of our customer’s needs, and we are committed to delivering personalized services with effective scientific results.
Our integrated CMC services are tailored for a drug candidate from late-stage discovery or pre-clinical development. We excel in:
As a drug candidate moves towards an IND filing and first-in-man trials, we deliver expertise in:
As the program progresses to Phase II and beyond to commercial launch, we continue to support our customers' active or intermediate ingredient needs by providing seamless scale-up support from the kilo-lab, to the pilot plant, to commercial supply. Our scale-up services include: