We about us
QX Pharma is an international consulting company based in Syke, a city on the outskirts of Bremen. Our main area of business is the support of the pharmaceutical industry. We can answer your theoretical questions and support you to find practical solutions.
Our multilingual staff with offices in Germany and in China is at your service.
Please check our services and see how we can support you.
QX Pharma, your reliable pharmaceutical support team!
Audits according to the
ICH or EU GxP guidelines
Our Lead Auditors have performed a large number of audits worldwide. We have audited for our European and US-clients suppliers in China, India, Taiwan, Japan, Korea, Indonesia, Thailand, Malaysia, Mexico, Switzerland, Lithuania, Germany, Denmark, and Italy. Furthermore, we have also audited for our Indian, Japanese, and Taiwanese clients factories in China, as well as and German factories for our Chinese customers.
Wherever your supplier is located; we are ready to go!
We have experience and have performed API suppliers for normal chemical APIs, as well as antibiotic APIs, hormonal APIs, genotoxic (anti-cancer) APIs, and APIs according to the Chinese Traditional Medicines, tea products and European plant products. Some of these production processes were sterile. There have been also audits of chemicals and intermediates, as well as sterile and non-sterile packaging materials. In regard to final pharmaceutical products, we have assessed manufacturers for tablets, soft- and hard capsules, gels and creams. We are also specialised in sterile injectables. Additionally, there have been audits for excipients, food supplements and sugars. Transport companies for APIs and final products, have been on our list, as well as printing companies.
Name your supplier, we have the experience and the know-how to perform the audit.
It goes without saying that our auditors are multi-lingual in regard to German, Chinese, English, Japanese and Italian. Our lead auditors are Europeans with a PhD.
There is a possibility that we have already audited your product and your supplier in the last one or two years, and we can supply you with a copy of the audit report.
Contact:
Christine POHL
E-Mail: Christine.pohl@QXPharma.de
Tel.: 0049-172-4149602
Inspections by the EU Authorities
We prepare API manufacturers for inspections by the German Regierungspräsidien, as well as other European Authorities, including the EDQM, or the US FDA.
QX Pharma, your experts regarding Inspections!
Pharmaceutical Manufacturers of
injectables and vaccines
The pharmaceutical standards for the manufacturing of sterile injectables and vaccines are very high. To prepare a facility for such a task is difficult and takes time. We have well trained staff, who can reside at the factory to prepare the production. Our consultants are trained to assess the different clean area requirements, including the specifications of the environment. They can draft SOPs and documents, like the Contamination Control Strategy (CCS). They can organise procedures like the media fill (Aseptic Process Simulation; APS).
We have also seminars including examinations for QA, QC and production personnel. The training units can be done in German, English and Chinese.
QX Pharma, your experts regarding sterile injectables!
PDE Reports
To register a pharmaceutical product in the European market, a large quantity of data has to be provided to the relevant Regulatory Authorities. This includes several expert reports. It should be noted that these expert reports have to be accompanied by a signed curriculum vitae, including certificates to prove that the expert has the academic education and continuous training, as well as the experience to provide these expert reports. One of these reports is described in the guideline EMA/CHMP/CVMP/SWP/169430/2012 for setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities from the EMA (European Medicine Agency), the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) is such a report.
Our experts have access to all relevant toxicological databases, the academic credentials, and the experience to provide these toxicological reports for your APIs and your final pharmaceutical products. Because the amount of information regarding the toxicological, teratological, pharmaceutical and pharmacokinetic studies, which are required to be assessed, as well as the length of the resulting report, may differ substantially between different APIs and final products, it is not possible to have a standard price for all reports. If you are interested to obtain such a report, please, provide us with the product details for a quote:
Contact:
Christine POHL
Email Address: Christine.pohl@QXPharma.de
Tel.: 0049-172-4149602
QX Pharma, name your missing documents!
Product registration in Europe
We have our own registration unit in a sister company. The unit has successfully submitted creams, gels, ointments, liquids and tablets in many European countries (EU members).
If you are interested to discuss details about the registration of your pharmaceutical product in one or more EU countries, please, contact:
Contact:
Christine POHL
Email Address: Christine.pohl@QXPharma.de
Tel.: 0049-172-4149602
QX Pharma, your experts in the EU!
Implementing and Supervising your Toll Manufacturer
If required, we supervise not only the implementation of the EU-GMP, but also the technical transfer of the analytical, as well as the production validations, including all the other requirements for this API or final dosage form.
Contact:
Christine POHL
Email Address: Christine.pohl@QXPharma.de
Tel.: 0049-172-4149602
QX Pharma, your experts in the EU!
If you are interested to discuss details about the registration of your pharmaceutical product in one or more EU countries, please, contact Christine POHL:
Christine.pohl@QXPharma.de,
Tel.: 0049-172-4149602
QX Pharma, your experts in the EU!
Seminars & Training
We are capable to give seminars, workshops and on-site training units regarding the EU-GMP regulations in German, English and Chinese.
Christine POHL
E-Mail: Christine.pohl@QXPharma.de
Tel.: 0049-172-4149602
