The Company

Healthbare Region Berlin-Brandenburg

The company has been founded in 2012 in Munich, Germany.In  January 2014 the PharmACT AG has relocated from Munich to Berlin-Brandenburg, located in the EUROPARC Dreilinden, in the southwest area of the city of Berlin.

Continouly the management team will be expanded. In 2014 the diabetologist, Prof. Andreas Pfützner, MD, PhD could be obtained for the management board of the company. He has more than 15 years of experience in clinical research, realizing clinical studies and a lot more. For the company a reason to be secure getting the approval of the medicine at the Federal Drug Agency (FDA), the US, and the European Medicines Agency (EMEA), Europe within a short period of time.

In Q4.2014 the operational start of the developement laboratory has been established in Mainz. After regulatory approval of the production area we will start with the commercialization of BelACT.

The first new product is BelDIA PRE, is a risk screening test for measurement of intact proinsulin in human capillary blood. The product is available in the European Union, Egypt and other Mediteranien Countries.

PharmACT AG is privately funded and independent.

Quality Management

Base for our work is ISO 9001:2008

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We are working in line with the rules of ISO 9001 for controlling at any time the business processes of PharmACT. ISO 9001:2008 offers a structured flexible framework for this. This framework will also be applied to our customer oriented business management system. Our aim is always increasing our performance and securing the company.

The norm ISO 9001:2008 includes hereby all aspects and actives of an organization including the identification of the most important business processes.

Eight quality management principles can be applied to the improvement of the organizational performance:

  • Customer orientation
  • Leadership of the Company
  • Involving the Employees
  • Process-oriented organizational approch
  • System-oriented management approach
  • Continuous Improvement Process 
  • Fact orientated approach for finding decisions
  • Customer-supplier relationship for mutual use

We are taking advantrage of using ISO 9001 as an organizational tool as follows

  • Measurable improvement of the financial success after introduction of ISO 9001 in non-certified companies
  • Higher motivation of employees by knowledge of own functions making the effect of their work transparent.
  • A good organisation has a significant effect on the performance of operational processes. The productivity is increased by minimizing mistakes, and the costs are also reduced.
  • Continuous improvement of the quality enables the company to provide high quality products and services. The customer satisfaction increases.

Our solution for QM of Medicinal Products

As Life Science company we have to observe a lot

As a life science company we have to observe a lot of different things, i.e. environmental protection, meeting regulatory requirements, laws, and also the protection of all internal requirements and responsibility of the company. We are one of more than 5.000 organizations in more than 60 countries being involved in the development of medicinal products.

Our critical processes must be supervised and automatically alert us on deviations. For this, we use an effective risk management system in the company.

Our risk management system is based on the Norm ISO 9001 and is supplemented by a process norm according to ISO 13485:2009. Thereby, the requirements of our customers and for our medicinal products and services related to the fulfillment of all legal requirements are supposed to be followed. Especially medicinal products and life science products must meet several national legal requirements; this is the pre-request for market entry.

 

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Our Risk Management

Methods of our risk management system

The Risk Management System of our company is built on regulation and norms as the COSO ERM (www.coso.org), the ONR 49000 - Risk Management for Organisations and the requirements of ISO 31000. We are receiving a countinuous valuation of the company across all business processes.

The valuation is performed in a team, by the management team and the single business units of PharmACT AG. We have a balanced view of the status of the company provided online. In order to achieve this we are using the system provided by the Swiss softwarehouse acumentum. 

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