We provide overall project management for compliance actions as well as being able to provide issue specific support on:

  • Consent Decree / Injunction. We have successfully undertaken remediation programs with "no 483 findings" outcomes
  • Recall Management
  • Design Verification / Design Validation protocols
  • Process Validation protocols including those related to a Controlled Environment and HVAC Systems
  • Validations to specific design (e.g. to 10993 and its subparts) and process standards (e.g. VDMAX methods).