ChemDiv's Chemistry, Manufacturing and Control (CMC) capabilities are fully integrated into the drug discovery and development process. We support drug substance and drug product development and GMP manufacturing for our global customers and partners.
We offer process R&D and chemical development services, large scale manufacturing for advanced intermediates and starting materials, manufacturing of APIs, formulation development and product characterization, analytical method development as well as validation/cross-validation and CTD support for regulatory filings among other services.
Our teams are composed of multi-disciplinary and highly experienced scientists with the deep knowledge of and expertise in every step of the pharmaceutical product development, from laboratory to commercial scale for both API and drug products. ChemDiv creates robust development strategies tailored to the characteristics of each individual product and through access to its well-equipped preformulation and formulation development laboratories rapidly and efficiently identify the most appropriate development approach to overcome any bioavailability challenges. This allows critical risk mitigation and successful project execution to our customers' full satisfaction.