Prolajm

Experienced Project Manager & CMC Expert

I offer expert services to Life Science companies focusing on development of medical devices and pharmaceuticals. Services include planning and management of development projects.

Services also include performing project activities such as

  • product development for clinical trials / clinical investigations
  • outsourcing of manufacturing
  • tech transfer to CMO and CRO
  • CMC support and coordination including formulation development, analytical development, and stability studies
  • CMC documentation for clinical trials (IMPD/IND) and handling of CMC questions from authorities
  • technical documentation for medical devices
073-373 07 53