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Parenteral preparations customized for patients

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Page 1: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

Parenteral preparations customized for patients

Page 2: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

MEDIOS MANUFAKTUR

Page 3: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

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 ex- perience 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

MediosManufaktur

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MEDIOS MANUFAKTUR

Our expert staff manufacture the preparations for your patients in accordance with the hig-hest quality and safety standards, working under aseptic conditions.

The production process follows the strict inter-nationally recognized GMP guidelines.

Every prescription we receive undergoes plau-sibility testing and every product goes through a number of quality tests before it is released for delivery.

We respond fl exibly and quickly to rapid ad-justments in treatment and fulfi ll all orders on time without exception.

Our services Pharmaceutical expertise

Our experts are happy to discuss any pharma-ceutical 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 emer-gency 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 aboutbil-ling 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.

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MEDIOS MANUFAKTUR

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 pharma-ceuticals.

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 simulta-neously ensure our quality management system, which mandates all processes.

Page 6: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

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

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MEDIOS MANUFAKTUR

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 profes- sional 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 ma- nagement in pharmaceutical decisions

Page 8: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

MEDIOS MANUFAKTUR

From placing an order to infusion:The process of collaborating with the contract manufacturer Medios Manufaktur is fast, safe and uncomplicated.

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

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MEDIOS MANUFAKTUR

Page 10: Parenteral preparations customized for patientsmediosmanufaktur.de/en/wp-content/uploads/sites/3/2017/07/medio… · Parenteral preparations customized for patients . MEDIOS MANUFAKTUR

MEDIOS MANUFAKTUR

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 +49 30 - 8471 210 - 710

We would be delighted to give you a guided tour of our facilities. Or visit our homepage to take a virtual tour:

www.mediosmanufaktur.de

Annika Wittke Pharmacist 

M +49 151 – 727 338 13E [email protected]

David Karlsch Key Account Manager/ Field Sales Representative

M +49 160 – 965 465 59E [email protected]

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MEDIOS MANUFAKTUR

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 exper-tise 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 expen-sive treatment that is usually customized.

Managing Directors  of Medios Manufaktur

Claudia NeuhausManaging Director

Stefanie KearneyManaging Director

Annette JörrenManaging Director

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Medios Manufaktur GmbHLuisenstrasse 54/55 10117 Berlin

T +49 30 - 8471 210 - 710T +49 30 - 8471 210 - [email protected]

Luisestra

sse

Fried

richstra

sse

Invalidenstrasse

Reinhardtstrasse

Berlin

HBF

Chaussestrasse

Hessischestrasse

Virchoww

eg

Alexa

nd

erufer

Virchowweg

Sauerbruchweg

Schummannstrasse

Virchoww

eg

Hannoversche Strasse

Torstrasse

Hannoverschestrasse

U Oranienburger Tor

Bus and tram stop: Invalidenpark

Max-Planck-Inst itutInst itute for Infect ion Biology

MediosManufaktur

How to get to Medios Manufaktur

Luisestra

sse

CharitéCampus of Charité

Universitätsmedizin