Formulation development, sterile manufacturing, and commercial launch at an FDA-inspected, DEA-registered facility with three decades of manufacturing history.
Engage our cGMP (GLP) analytical laboratory on its own, run manufacturing on its own, or combine both in one program.
Release and stability testing, method development, and batch verification for sterile and oral products. Samples can be submitted directly.
Explore testing →CMC development through commercial launch: formulation, tech transfer, clinical and commercial cGMP manufacturing, serialized packaging, and distribution.
See full capabilities →Formulation and analytical development, technology transfer, clinical and commercial cGMP manufacturing, and packaging with serialization, at one FDA-inspected site in San Diego.
Physical characterization, excipient compatibility, dosage-form design, solubility assessment, process design and scale-up. Full cGMP QC and analytical labs in-house.
Structured transfer of products and process knowledge: control strategy, process qualification, and manufacturing readiness on schedule.
Clinical supplies for programs at every stage, including matching placebos, with phase-appropriate systems that support trials worldwide.
Scale-up and second-source qualification. Automated packaging lines with serialization and track & trace, controlled-temperature warehousing with DEA vaults, and global distribution.
Quality systems aligned with FDA, DEA, and international health authority requirements, maintained across three decades of U.S. manufacturing in San Diego.
More about the facility →24,400 square feet of cGMP development, manufacturing, packaging, and laboratory space, continuing more than 30 years of pharmaceutical manufacturing in San Diego. Our mission today: re-shoring drug manufacturing and supply chains to the United States.
30+ years of cross-border pharma between the US/EU and Asia: tech transfer, licensing, M&A, and manufacturing strategy.
25+ years in biopharma. Licensing and BD leadership at Merck, CEO of Castle Creek Pharma, Managing Partner at TardiMed.
US-based pharmaceutical development and manufacturing in San Diego, California.