TRC's approach to new product introduction is based on the quality by design framework to characterize your product at each stage of the development lifecycle. We provide a complete turnkey process that can be customized to meet your drug product development, clinical, and registration requirements.
We have a dedicated team of scientists, engineers, and regulatory professionals to provide full manufacturing process development services, including pilot studies and clinical batches, all of which are scalable for commercial batch production. TRC maintains fully functional chemistry and microbiology laboratories capable of development, transfer, and validation of analytical test methods in support of product formulation, extractable and leachable studies, stability studies, validation studies, and clinical supplies.
TRC takes a straightforward approach to establishing agreements with our clients. First, we initiate a two way nondisclosure agreement so that we can establish a confidential dialogue about your product and process. Once we have the nondisclosure in place, we provide you with a comprehensive product information gathering form to help us better understand your needs and how we can best meet them. Based on this information, we will provide a detailed proposal for your review. As soon as we reach an agreement on the proposal, a detailed development agreement is drafted. This process typically takes place in parallel with a more detailed project definition process that will involve members of our development as well as quality and operation groups. The goal of this step by step process is to develop a comprehensive, cost effective and efficient project plan and development agreement that meets the needs of both parties.
The Research and Development building was completed in 2008. This is a key milestone that demonstrates our commitment to helping our partners achieve success.