Diagnostic Systems

Vacancies

Currently there are no open positions at PharmGenomics. But we offer the possibility to prepare theses in the areas of biology, biotechnology, biomedicine and (bio-)informatics. Please send your application documents to This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Sponsorships

PharmGenomics GmbH is sponsored by the following institutions:

 

Quality Policy

February 10th 2011

PharmGenomics GmbH declares the following quality policy:

PharmGenomics GmbH has established and maintains a quality management system based on good and professional practice and follows international standards and guidelines concerning quality management. To implement and continuously improve the established QM system, the company management appointed a quality management representative. The QM system is based on the following principles and characteristics:

Service

Time appropriate and in accordance with legal obligations, the PharmGenomics GmbH sees itself as a provider of quality assured products and services to their customers. The quality of the provided services is continuously evaluated and adapted to the current state of knowledge and technology. This is done according to content, as well as relating to response times towards interest groups.

Management

The PharmGenomics GmbH understands quality as a function of management and employs quality-oriented knowledge and appropriate actions to construct a quality-promoting organisational structure. The executive boards established at the PharmGenomics GmbH (company management and laboratory management), commit to provide any resources necessary to maintain the QM system as well as to apply accepted quality techniques to secure an adequate culture of quality. The genetic diagnostics laboratory commits to conform to the effective legal regulations regarding medicinal products, as well as the international standards DIN EN ISO 15189 and DIN EN ISO/IEC 17025. Analogous, the research laboratory commits conformity to effective legal regulations regarding medical products and the international standard DIN EN ISO 13485. During in-house seminars, the quality strategies of the PharmGenomics GmbH are repeatedly communicated and the effectiveness of the QM system is demonstrated.

Employee orientation

The core elements of quality at the PharmGenomics GmbH are qualified personnel in all areas of the company and the respectful appreciation and development of the employees. For this reason PharmGenomics GmbH offers all employees adequate job-training as well as a continual further education program that is designed to improve independent, responsible and quality-assured working skills. Performance-oriented appraisal interviews, which are held on a regular basis, serve as an assessment of employee competency and additionally facilitate the continual evaluation of employee satisfaction. These measures are taken to constantly optimize the personnels’ skills and expertise. Occupational health and safety are also faced with new challenges due to the demographic change in the working population. Hence, PharmGenomics GmbH recognizes a need for action to create age-based working conditions, e.g. by an age-based personnel and company development, as well as age-based labour organisation. PharmGenomics GmbH rejects any predefined gender roles and instead promotes gender equality. Possible differences between men and women regarding safety and health at their workplace and in the community are taken into account.

Process- and System management

To ensure optimal completion of its duties and responsibilities, the PharmGenomics GmbH structures essential work processes and the necessary resources within the framework of process landscapes. Requirements and tasks posed to the PharmGenomics GmbH by external customers are assigned to the internal quality requirements of the company and its different divisions. Standardised processes are documented in a traceable and reproducible manner. They are managed in a structured documentation system that conforms to the respective standards. For the purpose of quality assurance changes are subject to a “change-control”-procedure.

Continual improvement

Continuous evaluation and improvement of performance and efficiency of the QM system are part of the permanent goals of the PharmGenomics GmbH. For this purpose, the following procedures, based on the Plan-Do-Check-Act cycle, are introduced and maintained:

  • recurrently performed self-assessments (e.g. in terms of internal audits and quality circles).
  • application of quality techniques regarding the area of problem and risk management, including the performance and efficiency assessment of corrective and preventive measures.
  • recurrently performed review of all aspects of the QM system.
  • evaluation of customer satisfaction.

Relevance

The implementation and further development of the QM system for PharmGenomics GmbH is based on an interdisciplinary-scientific approach in which processes are analysed with the help of valid and objective data, and which are optimised where necessary. An essential aspect of quality is the transparency of individual tasks and performed processes respectively. In line with this relevance, external services and suppliers are also subjected to an ongoing evaluation process to maintain the highest possible value creation.

Social responsibility

PharmGenomics GmbH aims to increase the trust and confidence of all interest groups associated with PharmGenomics GmbH and their services and products. In line with personnel management, PharmGenomics GmbH orientates itself by the values of social responsibility and ecological sustainability by an increase in ecological efficiency.

About the Company

The PharmGenomics GmbH was founded in 2008 with the idea to develop flexible and high quality solutions for the field of Personalized Medicine. By now our staff is made up of employees from the fields of biomedicine, biotechnology and (bio-)informatics. From 2008 to October 2013 PharmGenomics GmbH was located at Parcusstrasse near by the main central station of Mainz until the company moved to its new facility in Mainz Hechtsheim.

In our department of research and development we develop novel in-vitro diagnostic (IVD) test for clinical diagnostics in the area of pharmacogenetics and individualized medicine. Our products are based on a novel Macroarray-Technology, which allows for the first time the economic design of comprehensive pharmacogenetic examinations for clinical application. Thereby a large amount of various markers (i.e. mutations in disease-relevant genes) can be screened simultaneously. This multiplexing technique is highly suitable to prepare a comprehensive picture of several markers in short time and with proportionally low effort. Furthermore, the technology can be applied to a wide range of other bio-markers in the field of mRNA and proteins.

In addition to our research we have a diagnostic routine laboratory, in which the tests we developed are offered as services. This laboratory is accredited according to the norm DIN EN ISO 15189. Follow this link to find our current certificates available for download. Our goal is to promote both the positive progress of pharmacogenetics and individualized medicine through our research and developmental work, so that a fast and cost-effective pharmacogenetic diagnostic is possible directly at the point-of-need in the future.