- 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).