Services

  • Production under cGMP
  • Process R&D
  • Chemical process validation
  • Reference standard preparation
  • Analytical method development and validation
  • Specifications development
  • Stability studies
  • IND, NDA and ANDA filing assistance
  • DMF preparation
  • Technology transfer
  • Project management
  • Discovery intermediates
  • Discovery services (Shanghai Chemspec)
  • DEA Registration for Controlled Substances

Project Management

Effective, open and responsive project management is key to customer satisfaction. A project manager coordinates all aspects of a project and acts as client contact on a day-to-day basis. In addition, weekly progress reportsĀ are produced andĀ teleconferences arranged as needed.

Business Model

Chemspec-API offers clients the following service models alone or in combination:

  • Full Time Equivalent (FTE)
  • Fee for Service (FFS)
  • Fee for Project (FFP)

Work with us to chose the best, most cost-effective approach for your needs.