CMC Product Development

Increase the speed and quality your drug development projects with the Frontage Chemistry Manufacturing and Controls (CMC) group.  Expect high quality and timely delivery within budget.  Escape the frustration caused by numerous change orders requiring more resources for scheduled work.

 

Frontage provides sponsors with the certainty of firm budgets, smooth communications and the comfort that you won't get lost in the bureaucratic shuffle of a behemoth CRO.

 

Let Frontage help move your pharmaceutical program from the preclinical phase into clinical development with expert synthesis, preparation and testing of your active pharmaceutical ingredient (API) or organic compound for administration in vivo.

 

Advance your program with Frontage by accessing our CMC services, including:

 

  • Custom synthesis and development of active pharmaceutical ingredients (APIs)
  • Reference standards for finished product development
  • Analytical services for various dosage forms of related compounds
  • Analysis of stability, dissolution and other characteristics.

Producing solid, semi-solid, liquid and sterile dosage forms 

 

Operated under current Good Manufacturing Practices (cGMP), the Frontage manufacturing facilities are designed with the goal of producing solid oral dosage forms, as well as semi-solid, liquid and sterile products ranging from a few units up to 120 kg for solid dose, 350 kg for semi-solid and liquids and up to 10 liters for aseptic processes.

 

Additionally, our scientific and regulatory consulting group can provide the expertise needed to support the filing of INDs, NDAs and ANDAs with the Food and Drug Administration. Last but not least, Frontage scientists have the required knowledge and expertise to support the technical transfer of the process and analytical methods to the sponsor’s facility.