contract development and manufacturing services.
Since 2018, Cosette has offered comprehensive contract development and manufacturing services solutions that include product development, technical transfer, scale-up, manufacturing, packaging, serialization/aggregation, stability programs, and testing services. Cosette owns and operates a state-of-the-art R&D center in South Plainfield, NJ, as well as a commercial manufacturing facility in Lincolnton, NC. Both facilities have been successfully inspected by the Food and Drug Administration (FDA) as recently as 2023. Cosette is helping customers to bringing innovative therapies to market faster and by developing innovative solutions for oral and topical liquids, semi-solids, and suppositories.
commercial manufacturing.
Nestled on 12 acres of land, our expansive 150K+ sq. ft. manufacturing facility, established in 1989, is focused on driving pharmaceutical manufacturing excellence. Boasting a dynamic team of 250+ dedicated professionals, we excel in a spectrum of commercial dosage forms from fill to finish, including oral & topical liquids, semi-solids, and suppositories.
product development.
With a 20K sq. ft. R&D laboratory, Cosette boasts a dedicated team of 50+ experts. Our lab drives the development of oral and topical liquids, semisolids, and suppositories. By providing product development and analytical R&D services, we ensure that your vision becomes a reality. We have the capability to perform method development, method verification, method validation, and technical transfer to our manufacturing facility in Lincolnton, NC. As a one stop hub, we provide In Vitro BE (Q3/IVRT/IVPT) studies, reverse engineering, method remediation, management of stability studies, and clinical project management.
quality.
With an unwavering commitment to quality, Cosette’s R&D laboratory and commercial facility boasts a stellar CGMP and compliance track record. Our dedicated Quality Department ensures that every aspect of your project adheres to the highest industry standards. From meticulous raw material sourcing to stringent manufacturing processes, we prioritize quality at every step.
capabilities.
South Plainfield, NJ | Lincolnton, NC | |||
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Dosage Form | ||||
Creams / Gels / Ointments | • | • | ||
Lotions / Shampoos | • | • | ||
Oral Liquids (Solutions / Suspensions) | • | • | ||
Suppositories | • | • | ||
Research & Development | ||||
Product Development | • | |||
Analytical R&D | ||||
Method Development | • | • | ||
Method Validation | • | • | ||
Method Verification | • | • | ||
In vitro BE (Q3/IVRT/IVPT) | • | |||
Reverse Engineering | • | |||
Method Remediation | • | • | ||
Stability | • | • | ||
Commercial Activities | ||||
Technical Transfer / Scale-up | • | |||
Manufacturing | • | |||
Packaging | • | |||
Serialization / Aggregation | • | |||
Raw Material Testing | • | |||
Finished Product Releasing | • | |||
Microbial Testing | • | |||
Stability | • | |||