• Setting up a quality system
  • if you are making or already have made the switch to production of clinical trial material, a quality system needs to be built.
•  Setting up a quality documentation system
  • Part of the quality system is the documentation system. This consists of SOPs, Site Master File, work instructions, etc.
•  Performing GMP audits
  • If you are using external laboratories, or production facilities, you need to verify whether these sites work according to GMP. Svinx Consultancy can perform audits for you on these sites.