Development and management of a seamless manufacturing supply chain is critical to the success of your product. We understand that in order to realize this success, our clients may require assistance in: development of specifications, determination of appropriate in-process controls (IPC), phase-appropriate validation of analytical test methods, stability study design, as well as writing CMC sections of regulatory filings. Our team members can provide expertise during the development and scale-up of your manufacturing process, including the selection of qualified manufacturing and testing vendors to propel your product into nonclinical testing, clinical development, and ultimate commercialization. Whatever your needs in CMC are, we can provide a flexible solution for you.
The development of indication-specific nonclinical testing programs to support the conduct of clinical trials is a specialty at Development Insights, and we understand its importance to your success in clinical development. Our nonclinical and translational research team members have expertise in: design of IND-enabling toxicology studies, bioanalytical method development, evaluation of TK/PK data, biomarker selection, and technical review of study protocols and reports. In support of regulatory filings, we can write nonclinical sections, and also provide support in the development of associated clinical documents, such as the Investigator’s Brochure (IB) and Informed Consent Form (ICF). Development Insights can provide the industry knowledge to ensure that your nonclinical testing pathway will augment your clinical development plans.