Comotion Drug Delivery Systems Inc.

Comotion Drug Delivery Systems Inc. is an international organization registered to receive federal contract and grant awards from the U.S. government. The company specializes in drug delivery systems and pharmaceutical manufacturing, with a focus on developing and producing advanced medical products for therapeutic applications. As a minority-owned, Asian-Pacific American owned business, Comotion qualifies for certain set-aside designations in federal contracting. The company has been registered in SAM.gov since September 2020, indicating its relatively recent entry into the federal marketplace.

Comotion has participated in federal contract work as a subcontractor to Versiti Wisconsin, Inc. Their contract activities have centered on developing analytical methods for assessing thrombin and tranexamic acid (TXA) in medical gauze products. Specific tasks have included developing and validating analysis methods for TXA and thrombin in counterflow gauze, preparing regulatory submissions to the FDA, and establishing Good Manufacturing Practice (GMP) processes for producing medical gauze products. The company has been involved in preparing Investigational Device Exemption (IDE) and Investigational New Drug (IND) applications, demonstrating their role in advancing novel medical technologies through regulatory pathways. Comotion's contract work has also encompassed upgrading manufacturing equipment, establishing processes for integrating barium threads into gauze fabric, and producing pilot batches of up to 2,400 units of counterflow gauze under GMP conditions for use in preclinical studies.

In the realm of federal grants, Comotion has served as a subgrantee to Versiti Wisconsin, Inc. on projects funded by the Department of Defense. Their grant-related activities have focused on manufacturing and characterizing refined formulations of a product called Counterflow-AP. This work has included producing batches for testing at various research sites, transferring manufacturing processes to contract manufacturing organizations (CMOs), and developing quality control methods and product specifications. Comotion has been tasked with screening excipients, refining manufacturing processes, and validating production methods. The company has also been involved in developing packaging and sterilization methods for the Counterflow-AP product, as well as conducting stability testing under various climatic conditions. These activities demonstrate Comotion's expertise in pharmaceutical manufacturing, quality control, and product development within the context of federally funded research projects.