Company Profile

 

Activoris is the German medical device and pharma specialist, building up on decades our-valueof management experience in the medtech and pharma industry.

No matter if you are looking for a development and manufacturing partner,  supply of clinical trial material or if you need strategic advice. We support our clients in setting-up and executing their projects. We help with defining the development strategy and product concepts, regulatory strategy building prototypes, GMP compliant clinical supply, and take care of design transfer and launch Management.

Service Overview

 

ServiceGridEN

Management-Team

 
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Axel Fischer

Founder & Chief Executive Officer

Before founding Activoris, Axel gained over 18 years of life science industry experience. He had roles with increasing responsibility in iv-Diagnostics, Lab Software, MedTech and Pharma.

In his last position at Activaero GmbH, Axel was Managing Director, COO. In this role, Axel was responsible for production, logistics, alliance management, QM and IT. Axel established multiple licensing and collaboration partnerships with biotech and pharma. He carries extensive knowledge about sourcing, technology partnerships and contract management in the life science industry.

Before joining Activaero, Axel spent one year as a Sales & Marketing Manager at Intellitec GmbH. Axel started his professional career at Siemens HealthCare Diagnostics as a Software Project Manager withtin the European Marketing Organization.

Axel holds a degree in business administration/marketing by the Fulda University of Applied Sciences.

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Dr. Stefan Degenhardt

Founder & Chief Financial Officer

Stefan brings to Activoris 15 years of financial experience in senior management positions. Stefan was the CFO at Activaero GmbH, and as a member of the management team, he was responsible for accounting and controlling of the three business lines clinical research,  technology licensing and device distribution. Also, he led the foundation and financing of Ventaleon GmbH, a project company in the field of influenza research.

Before joining Activaero, Stefan gained 11 years of finance experience with increasing responsibilities in the CRO business. As the CFO of EPA Europharma, later acquired by Premier Research, he headed the finance and administration department. During his time at Pharmapart, he implemented systems and processes for improved controlling and reporting for international clinical research projects. After the acquisition by Pierrel Research, Stefan re-structured the international corporate administration and finance department.

Stefan holds a PhD in economics by University of Kassel.

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Dr. Thomas Julien

Director Production & Logistics

Dr. Julien knows the recent quality management systems in pharma and medical devices, and has a long-term experience in aseptic and parenteral manufacturing, lyophilisation, tablets, capsules and suppositories. He is a Qualified Person for „normal Products“, Authorized Person for Controlled Drugs and is eligible to approve clinical samples.

Dr. Julien started his professional career in 1987 at former Behringwerke in Marburg/Lahn. Since then, he held several senior positions in different pharma and diagnostics companies. From 2005 through 2008, he was head of pharma production at Baxter Oncology, Inc. in Halle/Westfalen. Dr. Julien changed to Haupt Pharma Wülfing (Gronau) in 2009, where he was appointed as Managing Director. In 2014, Dr. Julien changed to Next Pharma, where he took over responsibility for the site in Göttingen.

Dr. Julien achieved a diploma in Chemistry from Goethe University in Frankfurt and holds a PhD in Bio-chemistry from Max-Planck-Institute for Biophysics in Frankfurt/Main.

Quality Management System

 

Dear Business Partners,

Medical devices and pharmaceuticals should support patient’s health and well-being. Considering the technical complexity of today’s innovative and more intelligent products as well as new materials and new active substances, one has to recognize that, at the same time, each product presents a potential risk. Moreover, modern medical technologies and drugs need to be provided in a cost-efficient manner in order to achieve re-imbursement, and finally, reach the patient.

At Activoris, we strive to provide our customers with high-quality products and services, representing the ground for their successful marketing. We want to achieve the highest customer satisfaction under the framework of the actual budget. Being aware that Activoris forms an important factor in the life cycle of a medical device or medicine , we particularly feel responsible for the quality of our service.

We cannot neglect that a company needs sustained economic success to survive on the market. Thus, achieving profits is a legitimate objective at Activoris. And we believe that success can only be realized and preserved if we appreciate the needs of the people working in our organization.

At Activoris we want to establish a climate of responsibility, openness, enthusiasm for the customer, mutual support, respect without prejudice, and pleasure in achievements.

We are committed to quality to provide services and products that meet customer requirements as well as legal requirements. To support our claim, the management of Activoris has decided to implement and maintain a quality management system according to

DIN EN ISO 9001:2008 and DIN EN ISO 13485:2012
Under consideration of Good Manufacturing Practice for Pharmaceuticals and Clinical Samples

wich is monitored and improved on a regular basis. Special requirements for sterile products, active implantable products (AIMD) and in-vitro Diagnostics (IVDs) are excluded from the quality management system.

Every employee at Activoris is liable to know and adhere to the relevant company standards and regulations, and, further should actively contribute to improve our quality management system.

Dr. Stefan Degenhardt und Axel Fischer

pdf-icon-1 Activoris Certificate 13485

pdf-icon-1 Activoris Certificate 9001

pdf-icon-1 Activoris Zertifikat 13485

pdf-icon-1 Activoris Zertifikat 9001

pdf-icon-1 GMP Certificate Activoris DE-EN

pdf-icon-1 Manufacturing Authorization Activoris DE-EN