Health Authority Inspection

Bringing experience in successfully managing dozens of sponsor and site inspections (FDA, MHRA, EMA, CFDA, etc…), ObelysQ will provide your organization with an efficient and collaborative management of all Competent Authorities GCP inspections to maximize the chance of a successful outcome, while engaging your staff and decreasing anxiety.

Our collaboration will include the development of a specific inspection plan, evaluation of the risks and potential issues in every aspect of your program/study, communication with all relevant staff, training, interview coaching, set up of the inspections facilities, inspection hosting and/or back room support, development or responses to inspection findings. You can pick and choose depending on your needs and the nature of the inspection.

ObelysQ has also prepared inspection guides to help you and your organization understanding all steps necessary to be inspection-ready.

Inspection preparation

  • Development of a specific inspection plan
  • Evaluation of the risks and potential issues in every aspect of your program/study
  • Communication with all relevant staff, training
  • Interview coaching

Mock Inspection

Would you like to see if you are inspection ready?

ObelysQ can conduct mock inspections in the style of the competent authority that will be inspecting you. This exercise allows your team to get a real feel of the inspection process and also get direct feedback on their performance during interview and efficiency of document request management.

Inspection support

  • Set up of the inspections facilities
  • Inspection hosting and/or back room support
  • Development or responses to inspection findings