Cognate's mission is patient-focused, and as such we have to focus on the product lifecycle from start to finish to ensure the highest quality products are made and delivered. Whether we work with you on product handling or collection procedures for the starting materials, or a custom shipping protocol for patient administration, Cognate has helped and can work with you to meet your needs. Our regulatory team can work hand-in-hand with your dedicated team on all aspects of the product development and commercialization plans, submissions, and inspections.
Other services that have created value to our clients' programs at various stages of development include clinical site optimization, clinical site education, on-site and off-site storage, and custom product/packaging logistics, and dedicated QP services.
We have a long history of coordinating with multiple international regulatory agencies at various stages of clinical and commercial development. We leverage this experience for our clients to help establish or augment the clients’ respective regulatory and/or clinical packages.
With rapidly evolving technology, it is imperative that clients have access to a CDMO with experience across a wide variety of product configurations and at all stages of development—complemented by a fundamental commercial mindset. Cognate has the experience to understand and foresee how changes can impact products. Our custom services help our clients effectively bridge the gap between the known and unknown, or your current state and future state.
Our clinical operations team has 20+ years in cellular therapies navigating the relationship between manufacturing, your CRO, clinical sites, and our client’s team. The team has performed hundreds of site initiations for our clients to ensure robust processes for patient material shipping to manufacturing, proper labeling, scheduling, procedures, training, and logistics complexities including customs documentation for international shipment of time-sensitive products.