Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, signed a master service agreement (MSA) with CivicaScript.

The agreement covers an initial project supporting a generic drug candidate that is moving through development and registration efforts, with the potential to expand to include support of additional CivicaScript programs.

Under terms of the agreement, Societal CDMO will execute a range of services including analytic method and tech transfer, formulation development, process development, and non-GMP batch manufacturing. The work will then culminate in registration scale batch manufacturing to produce clinical trial materials intended for registration with the U.S. FDA. This will include registration batch bottle packaging, labeling, and clinical supply distribution.

“The work that we will conduct under this MSA with CivicaScript provides an excellent opportunity for Societal CDMO to showcase our team’s ability to support the full range of activities required for the development and registration of a generic medicine,” said David Enloe, CEO of Societal CDMO. “We are excited to team up with CivicaScript on this project as we share the company’s commitment to making an impact on the lives of patients. Their dedication to making quality generic medicines affordable and available to everyone fits well with our mission of bringing science to society.”