Formulation and analytical development, technology transfer, clinical and commercial cGMP manufacturing, and commercial packaging with serialization. Programs can enter at any stage: early formulation work, a transfer of an existing process, or established commercial supply.
01
Formulation & analytical development
Phase-appropriate development from pre-formulation onward: physical characterization, excipient compatibility, solubility assessment, dosage-form design, and process design with scale-up in mind.
—Analytical method development, qualification, and validation
—cGMP QC and analytical laboratories in-house
—Development batches on the equipment that will run them at scale
02
Technology transfer
Structured transfer of products and process knowledge, into or out of the facility. Used by sponsors moving supply onshore or qualifying a second source.
—Gap assessment, control strategy, and process qualification
—Engineering and demonstration batches before GMP runs
—Manufacturing readiness on a defined schedule
03
Clinical cGMP manufacturing & packaging
Clinical supplies for Phase I through Phase III programs, with phase-appropriate quality systems that support trials in the U.S. and worldwide.
—Matching placebos manufactured alongside active product
—Clinical packaging and labeling
—Controlled-substance programs under DEA registration
04
Commercial manufacturing & packaging
Commercial supply with scale-up support and second-source qualification, through serialized packaging and distribution.
—Automated packaging lines with serialization and track & trace
—Controlled-temperature warehousing with DEA vaults
—Global distribution
