Company Quality Management Audits and Inspections Regulatory Affairs and Pharmacovigilance Clinical Trials Audits and Inspections zelhealth offers GMP audits across the globe – either for your own facilities or your third party suppliers. We ensure that all audits that you have to conduct as MA holder are getting done appropriately. In addition we support you with all procedures that are required to comply with FDA and EMA regulations. We prepare your management and staff to pass FDA and EMA inspections. Example of the scope of Audits and Inspections Preparation of Internal Audit Agenda Conducting an Internal Audit Conducting a Gap analysis on-site to check the current compliance status of the relevant topics in Quality Management System, Production System, Facility and the Equipment System, Laboratory Control System, Material System, Packaging & Labelling System, Pharmaceutical Development and Technology Transfers to be in line with FDA or EMA guidelines Preparation and Submission of an Audit Report with detailed recommendations of how to achieve FDA or EMA readiness within four weeks after the completion of the audit. This report includes resource requirements, budget and possible timelines to achieve FDA or EMA readiness in phase II. In phase II we offer to implement our recommendations and to get the desired FDA or EMA approvals for you in cooperation with the relevant authorities. Preparation © 2015 ZELHEALTH GMBH zelhealth is an independent, privately owned pharmaceutical service company based in Hamburg, Germany. English Deutsch HEADQUARTERS Reventlowstraße 28 22605 Hamburg fon: +49 40 85337 630 fax: +49 40 85337 632 LOGISTICS CENTER Am Hasselt 21 24576 Bad Bramstedt fon: +49 4192 2010540 fax: +49 4192 8140224 CONTACT US Contact Imprint

Company Quality Management Audits and Inspections Regulatory Affairs and Pharmacovigilance Clinical Trials Regulatory Affairs and Pharmacovigilance © 2015 ZELHEALTH GMBH zelhealth is an independent, privately owned pharmaceutical service company based in Hamburg, Germany. English Deutsch HEADQUARTERS Reventlowstraße 28 22605 Hamburg fon: +49 40 85337 630 fax: +49 40 85337 632 LOGISTICS CENTER Am Hasselt 21 24576 Bad Bramstedt fon: +49 4192 2010540 fax: +49 4192 8140224 CONTACT US Contact Imprint

Company Quality Management Audits and Inspections Regulatory Affairs and Pharmacovigilance Clinical Trials This page can't load Google Maps correctly. Do you own this website? OK zelhealth GmbH Hamburg Bad Bramstedt Headquarters Reventlowstraße 28 22605 Hamburg fon: +49 40 85337 630 fax: +49 40 85337 632 www.zelhealth.com Logistics center Am Hasselt 21 24576 Bad Bramstedt fon: +49 4192 2010540 fax: +49 4192 8140224 www.zelhealth.com Contact Us Your Name (required) Your Email (required) Subject Your Message © 2015 ZELHEALTH GMBH zelhealth is an independent, privately owned pharmaceutical service company based in Hamburg, Germany. English Deutsch HEADQUARTERS Reventlowstraße 28 22605 Hamburg fon: +49 40 85337 630 fax: +49 40 85337 632 LOGISTICS CENTER Am Hasselt 21 24576 Bad Bramstedt fon: +49 4192 2010540 fax: +49 4192 8140224 CONTACT US Contact Imprint