ISO QMS Documentation


We can assist in writing of Quality Manual conformant with ISO 9001, ISO 13485, 21 CFR 820 and Canadian MDR.

We can provide Guidance and assistance in preparing of Working Instructions, Templates and Forms (level II and III documents)

Clinical Trial Center Audits 


In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

Early audits can identify systematic problems in the conduct of a clinical trial. Corrective actions will immediately contribute to project management success.

External audits offer more guarantees for independence from company’s procedures and operational units.
Studies, service providers and systems are audited against international and national standards, namely ICH GCP and the Clinical Trial Directive 2001/20/EC and GCP Directive 2005/28/EC, the relevant parts of the FDA CFR and ISO 14155




Quality Management Systems


· Reviewing current structure and policies, processes and documentation

· Assistance in writing, reviewing, updating and adapting standard operating procedures (SOPs) to your specific needs and minimum requirements

· Establishing a comprehensive and efficient system enabling a consistent quality structure

· Identifying and initiating corrective and preventative actions to continually improve your processes

· Inspection Readiness Assessments

· Quality Systems Training, Development and Implementation


Training 3


under construction

  • +972 52 6134368
  • P.O.Box 7746 Haifa, 3107701, Israel