Clinical, Regulatory and Custom Services

Cognate understands that high quality products need to be handled appropriately at all points from and then back into patients whether its allogeneic donors, or autologous patient specific product. The logistics, coordination and scheduling of the activities from the patient/physician to the CMO and then back to the patient/physician is critical and Cognate can create a process to ensure the right flow of information creates a seamless execution. We also understand that many of the patients we make products for are critically ill with little or no alternatives and that every minute counts. Let us work with you to create a process that is highly integrated and efficient for the patient, doctor, the drug developer and the manufacturing partner.

Other related services Cognate provides:

  • High quality products can rapidly become low quality products if they aren’t handled appropriately once they leave our facility. Clients who want to ensure that only the highest quality of products get administered to patients often consult with us to help educate the clinical sites on handling the products once they arrives on site.
  • Cognate’s long history of dealing with multiple regulatory agencies at various stages of clinical and commercial development can be leveraged by 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 several sectors and at all stages of development—in addition to 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 current state and future state.
  • So whether it’s a new assay, new sampling plan, new storage procedure and/or process, or a new device that needs to be modified to scale, or a new element of creating a closed manufacturing process that’s required, Cognate can help. No problem too small or too large for Cognate.