CUSTOpharm has established strong relationships with many contract manufacturing organizations (CMOs) both in the US and abroad to enable our clients to effectively manufacture a variety of dosage forms whether for use in clinical trials or commercial production. We specialize in injectable dosage forms, including lyophilized and cytotoxic compounds. However, we also have relationships with oral, ophthalmic, otic and nasal CMOs. These relationships enable our clients to meet aggressive timelines.
Working with established, reliable CMOs is essential to the development of pharmaceutical products. CMOs already used for applications will have experience with FDA audits and procedures including compiling the necessary regulatory documentation required for Regulatory Submissions. By using one of the CMOs that CUSTOpharm has a relationship with, CUSTOpharm can ensure a seamless integration with Development procedures and timelines.
Sourcing of Product Manufacturing is available as a stand-alone service or in conjunction with any of the other service CUSTOpharm offers including Product Development, Tech Transfer, Project Management, Regulatory Support, and our US Agent Service. Sourcing of Product Manufacturing is included with our CUSTOpharm Program. CUSTOpharm also offers a cost-effective strategy for contract manufacturing of sterile liquids. Please see our Contract Manufacturing website for additional information.