A Contract Manufacturing Organization (CMO), also known as a Contract Development and Manufacturing Organization (CDMO), serves pharmaceutical companies by providing a full range of services from drug development to manufacturing. This enables major pharmaceutical companies to outsource key business aspects, focusing on drug discovery and marketing while leaving manufacturing to experts.

CMO Services Include:

• Pre-formulation and formulation development

• Stability studies and method development

• Pre-clinical and Phase I clinical materials

• Late-stage clinical trial materials

• Scale-up, registration batches, and commercial production

In addition to manufacturing, CMOs offer flexibility, competitive pricing, and regulatory compliance. They ensure high-quality production aligned with the standards set by regulatory organizations like DRAP (Drug Regulatory Authority of Pakistan).

Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production. CMOs are contract manufacturers, but they can also be more than that because of the development aspect.

Their customers are not only expecting competitive pricing but also regulatory compliance, flexibility on the production capability and on time delivery. Overall it is required that CMO complies with good manufacturing practice from their client and official organization such as DRAP.