Management and execution of all CMC activities (click "How it Works" tab) that support IND's, NDA's, clinical studies, and preclinical studies.
Writing and defense of all CMC regulatory filings (including clinical protocols, investigator brochures, annual reports, etc.).
Direction leading to identification and selection of appropriate chemical and physical forms of API's.
Assist in selection with Request for Proposal documents of preferred, fully audited vendors for all CMC functions with years of proven performance of on-time delivery within budget.
Manage all aspects of contract API manufacturing in support of preclinical toxicology and preformulation/formulation studies.
Manage contract manufacturing of API's to support clinical development.
Highly cost effective experimental laboratory for non-GLP/non-cGMP preformulation studies and formulation design (sterile, non-sterile; all dosing routes).
Solubilization and controlled release technologies to optimize bioavailability.
Manufacture and testing of clinical supplies (Drug Product; CTM) at a level of rigor that is appropriate to the phase of clinical development and acceptable to regulatory bodies worldwide and management of technical transfer to phase-appropriate vendors.
Management of the logistics of clinical trial material distribution supporting domestic and worldwide clinical studies, including packaging design, labeling (foreign language translation) and worldwide cold chain distribution.
Management of the technical transfer from clinical manufacturing to commercial manufacturing on an international scale.
Management of registration batch manufacture, validation batches, and launch inventories, preparation of internal sponsor related SOPs and set-up for ongoing commercial supply.
We also provide expertise in:
Diligence evaluations of the CMC portions of investment or in-licensing opportunities.
Writing the CMC sections of internal diligence documents.
Drug/Medical Device Combination Products (510K and PMA regulatory routes).