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Quality Assurance & Audits

Clinical Trials Phase II - IVNon-interventional StudiesMedical Devices

Quality Assurance & Audits – Clinical Trials Phase II – IV

 

Quality assurance through audits is essential for a compliant conduct of your clinical investigations.

 

Our independent and experienced team of auditors at Winicker Norimed is specialized in quality assurance in clinical investigations. We conduct audits in accordance with current regulatory requirements at investigation sites on your behalf or at your premises.

 

Our auditors help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits at the Sponsor’s premises and the investigational sites
  • Recommendation of CAPA-measures in case of findings

 

Your contact for Quality Assurance & Audits – Clinical Trials Phase II – IV

Dr. Elke König

Dr. Elke König

Elke.Koenig@winicker-norimed.com
+49 (0) 911 / 9 26 80 8805

Quality Assurance & Audits – Nin-interventional Studies

 

Our well-established quality assurance measures help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits in the context of the regular quality assurance measures
  • Recommendation of CAPA-measures in case of findings
  • Consulting on the corrections of internal and external finding

 

Your contact for Quality Assurance & Audits – Non-interventional Studies

Dr. Elke König

Dr. Elke König

Elke.Koenig@winicker-norimed.com
+49 (0) 911 / 9 26 80 8805

Quality Assurance & Audits – Medical Devices

 

Quality assurance through internal audits is essential for a compliant conduct of your clinical investigations with medical devices.

 

Our independent and experienced team of experts at Winicker Norimed is specialized in quality assurance in medical device clinical investigations. We conduct audits in accordance with current regulatory requirements at investigation sites on your behalf or at your premises.

 

Our well-established quality assurance measures help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits at the Sponsor’s premises and the investigation sites as part of routine quality assurance programme and as preparation for potential regulatory inspections
  • Recommendation of CAPA-measures in case of findings

 

Your contact for Quality Assurance & Audits – Medical Devices

Dr. Elke König

Dr. Elke König

Elke.Koenig@winicker-norimed.com
+49 (0) 911 / 9 26 80 8805

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