pharmaceutical analytical documentation

The following types of consultancy servies may be provided:
  • Preparation and review of SOPs and policy papers related to pharmaceutical quality control and analytical CMC documentation
  • Preparation and review of protocols for validation of analytical methods
  • Preparation and review of method validation reports
  • Preparation and review of protocols and reports for analytical method transfer
  • Preparation and review of impurity documentation for INDs, MAAs, NDAs
Working experience: senior scientist at analytical departments at Nycomed Imaging, Amersham Health, and GE Healthcare, altogether for 15 years.