Parenteral preparations customized for patients

Transcription

1 Parenteral preparations customized for patients

2

3 Medios Manufaktur Medios Manufaktur is a pharmaceutical manufacturer that produces infusion solutions customized for patients in ultramodern cleanroom labs. All preparations are produced on behalf of pharmacies based on an individual request from the attending physician and are made exclusively from finished pharmaceuticals approved in Germany. As a service provider with many years of experience in oncological supply, it goes without saying that we collaborate and work closely with physicians, hospitals, outpatient clinics and pharmacies. We guarantee first-class products of uniform quality and ensure that patients are safely supplied with their medication. Your team at Medios Manufaktur

4 Our services Our expert staff manufacture the preparations for your patients in accordance with the highest quality and safety standards, working under aseptic conditions. The production process follows the strict internationally recognized GMP guidelines. Every prescription we receive undergoes plausibility testing and every product goes through a number of quality tests before it is released for delivery. We respond flexibly and quickly to rapid adjustments in treatment and fulfi ll all orders on time without exception. Pharmaceutical expertise Our experts are happy to discuss any pharmaceutical questions you might have at any time, including drug compatibilities, side effect management or possible interactions. Provision of emergency kits We are happy to provide the appropriate emergency kits so incidents, for example, involving contaminated cytostatic drugs or extravasation can be handled properly. Presentations and trainings for highly qualifi ed specialized staff and patients With topics ranging from safely handling cytostatic drugs to optimal antiemetic treatment and preventing extravasation, we offer various lectures on supplying drugs given by infusion. Help issuing and billing prescriptions We are happy to advise you on how to issue prescriptions properly and can help you with any questions you might have aboutbilling health insurers. Support for legal questions We provide information about the current legal situation in the healthcare industry and about the most important innovations or changes. As an expert pharmaceutical partner, we would like to make your workday easier with our service.

5 Our products Parenteral preparations customized for patients from approved fi nished pharmaceuticals. from clinical test preparations (phases I-III). With many years of experience in trial drug support, we are your expert partner for your trials. We deliver all preparations as completely fi lled, ready-to-use infusion systems. Production based on GMP standards Quality assurance plays a central role in pharmaceutical manufacturing. With our GMP-compliant quality management system, we meet the requirements established by healthcare offi cials for market approval of our products. GMP (Good Manufacturing Practice) refers to the international guidelines on quality assurance for production processes and production environment in the manufacture of pharmaceuticals. The GMP guidelines establish standards for all relevant processes concerning quality assurance from the receipt of goods to manufacturing and distribution. By implementing these standards, we simultaneously ensure our quality management system, which mandates all processes.

6 MEDIOS MANUFAKTUR Quality management Comprehensive quality management according to the strict requirements of the GMP guidelines, which are globally applicable to the pharmaceutical industry Receipt of goods Supplier/manufacturer qualification required All source materials used are subject to well-defined inspection tests for incoming goods as required by law Production Maximum requirements for production rooms (size, technology, cleanliness, etc.) and production processes in accordance with the European Commission s GMP guidelines Elaborate, multi-stage cleanroom technology with high air-change rates and filter systems Continuous monitoring of the production conditions through microbiological monitoring, particle measurement and pressure monitoring

7 Staff Different departments with various managers and persons in charge: head of production, qualified person, head of quality control, managing directors Documentation of qualified person s professional experience Implementation and documentation of all employee training, as required by law Employee qualification checks Documentation All manufacturing processes are tracked through system-internal batches; the tracking begins with the receipt of the individual goods used as source material We comprehensively document and archive all manufacturer-related information for 10 years Monitoring Regular monitoring by the responsible authority Internal division of labor that supports compliance with GMP guidelines Qualified person s independence from management in pharmaceutical decisions

8 Physician Order of medication at pharmacy Pharmacy Plausibility check of prescription Prescription is ordered from Medios Manufaktur Medios Manufaktur Additional plausibility check of prescription Medication is manufactured according to GMP standards Pharmacy Delivery to physician Delivery to physician Physician Application of treatment From placing an order to infusion: The process of collaborating with the contract manufacturer Medios Manufaktur is fast, safe and uncomplicated.

9

10 Your contacts at Medios Manufaktur If you would like to speak with us, please don t hesitate to contact us. We can be reached by phone at the following number: T We would be delighted to give you a guided tour of our facilities. Or visit our homepage to take a virtual tour: Annika Wittke Pharmacist M E a.wittke@mediosmanufaktur.de David Karlsch Key Account Manager/ Field Sales Representative M E d.karlsch@mediosmanufaktur.de

11 Managing Directors of Medios Manufaktur Claudia Neuhaus Managing Director Stefanie Kearney Managing Director Annette Jörren Managing Director Medios Manufaktur is part of Medios AG Medios AG, along with its two subsidiaries Medios Pharma GmbH and Medios Manufaktur GmbH, has positioned itself in the specialty pharma segment as the go-to source for expertise and solutions. It brings together individual market players in a network of cooperating partners, to ensure that patients have optimum access to pharmaceutical drugs and to offer customized solutions along the value-added chain to partners. Specialty pharmaceutical drugs are medications for patients with chronic and/or rare illnesses (cancer, autoimmune diseases, infectious diseases, etc.) that require lengthy and expensive treatment that is usually customized.

12 Alexanderufer Luisestrasse How to get to Medios Manufaktur Bus and tram stop: Invalidenpark Invalidenstrasse Chaussestrasse Berlin HBF Virchowweg Hannoversche Strasse Luisestrasse Hessischestrasse Torstrasse Campus of Charité Universitätsmedizin Charité Hannoverschestrasse Sauerbruchweg U Oranienburger Tor Virchowweg Max-Planck-Institut Institute for Infection Biology Medios Manufaktur Friedrichstrasse Virchowweg Schummannstrasse Reinhardtstrasse Medios Manufaktur GmbH Luisenstrasse 54/ Berlin T T info@mediosmanufaktur.de