The foundations of safety

The companies in the axicorp Group are certified to DIN EN ISO 9001:2015 in order to manufacture and market medicines. In addition, there is the certification according to DIN EN ISO 13485 for the trade with medical products. To safeguard our quality pledge, we apply high standards and requirements consistently throughout all processes. Regular external and in-house audits guarantee a consistently high standard of quality. This is achieved on the basis of state-of-the-art technical standards and self-imposed obligations that go way beyond the measures required by law. All employees are actively involved in the continuous improvement and further development of the quality management system and receive regular training. This is the only way we are able to maintain our high standard of quality.

EU Counterfeiting Directive

With the entry into force of the EU Counterfeiting Directive, prescription drugs may only be marketed in Germany if they carry new corresponding security features. This should ensure protection against counterfeit drugs within the legal distribution chain and provide patients with safe medicines. The drugs concerned must have an individual identification feature and a safety closure.
Further information can be found in the explanatory video: 

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Good Manufacturing Practice

We follow the principles and guidelines of Good Manufacturing Practice (Directive 2003/94/EC), thereby laying the foundations for safe, high-quality medicines and medical products. We do this by using a quality assurance system that incorporates suppliers, transport (GDP), storage (GSP), manufacturing (GMP) and quality control (GLP).

axicorp procures its goods exclusively from qualified and regularly audited wholesalers in EU member states who are subject to constant medicines supervision and control by their responsible authorities. The employees of our quality control department, our production managers, our information officers and all other professionals involved are responsible for the correct documentation of all stages of manufacturing and testing, as well as for strict compliance with defined processes.


The building block for trust

Tested medicine safety

The axicorp Group operates a company-specific pharmacovigilance system in agreement with the Guideline on Good Pharmacovigilance Practices (GVP), Guideline 2001/83/EC (Art. 8) by the EMA. The safety profile and risk/benefits profile of medicines are also continuously reviewed (including through literature research and signal detections) and, if required, risk-minimising measures are taken. The company and each of its employees is obliged to obey the law, regulations and applicable requirements.

 

The axicorp Group operates a company-specific pharmacovigilance system in agreement with the Guideline on Good Pharmacovigilance Practices (GVP), Guideline 2001/83/EC (Art. 8) by the EMA.

The safety profile and risk/benefits profile of medicines are also continuously reviewed (including through literature research and signal detections) and, if required, risk-minimising measures are taken. The company and each of its employees is obliged to obey the law, regulations and applicable requirements.  

 

The axicorp Group operates a company-specific pharmacovigilance system in agreement with the Guideline on Good Pharmacovigilance Practices (GVP), Guideline 2001/83/EC (Art. 8) by the EMA.

The safety profile and risk/benefits profile of medicines are also continuously reviewed (including through literature research and signal detections) and, if required, risk-minimising measures are taken. The company and each of its employees is obliged to obey the law, regulations and applicable requirements.  

 

If there is any suspicion of an adverse drug reaction or an adverse event relating to a medical device, please notify us using our free service number 0800 2940 100 or use the forms below:

 

If there is any suspicion of an adverse drug reaction or an adverse event relating to a medical device, please notify us using our free service number 0800 2940 100 or use the forms below: