Assessment GCP Compliance

Profess performs GCP and ISO 14155 Compliance Programmes for Research Institutes and R & D departments of the pharmaceutical and medical device industry in full cooperation with the clients’ QA group. We have established the following methodology:

• Conduct a pre-audit to evaluate the current status (GAP analysis)
• Advise and propose action plans based on the findings
• Advise and give operational support to implement the changes
• Evaluate the new situation at regular intervals
• Document the results of the project in a final report

We can also assist the QA group with the development of SOPs. We build custom-made quality systems that are compliant with ICH GCP and ISO 14155 standards and the applicable regulatory requirements.