Project Management


  • 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).