Letters of recommendation for our pharmaceutical translation agency with a special focus on GMP inspections
GMP-inspection.com is a specialised interpreting and translation agency for the pharmaceutical sector with a special focus on GMP inspections and GMP audits for the English, Russian and German language. We have been translating and interpreting since 2010 and have since built up an excellent reputation thanks to our technical specialization. In 2021, our pharmaceutical translation agency GMP-inspection.com was spun off from our founding company AP Fachübersetzungen.
With our outstanding services, the interpreters from our pharmaceutical translation agency in Nuremberg have already convinced numerous well-known international manufacturers of active agents and excipients as well as sterile and non-sterile medicinal products during their GMP inspections by the Russian authority GILS i NP (for medicinal products for human use), the Russian authority VGNKI (for animal health), the Belarusian authority "Centre for examinations and tests in health service" and the American Food and Drug Administration. Our customer base also includes manufacturers of food supplements, feed additives, pesticides, cosmetics, a variety of systems and equipment as well as laboratories for pharmaceutical analysis and other players in the pharmaceutical industry. Above all, we owe the satisfaction of our discerning customers to our technical specialization in the fields of GMP and pharmaceuticals, the punctual and invariably reliable delivery of our translations, the excellent availability of our interpreters and our absolute commitment to customer focus. Expertise, discretion and confidentiality are the be-all and end-all of our work. We accompany the GMP inspection of your pharmaceutical company from the very beginning: Our GMP-inspection.com team translates all relevant documents in advance, supports you during the GMP inspection on site or in a virtual meeting (remote inspection) and ensures successful communication between GMP inspectors and all parties involved in the inspected pharmaceutical company. We are also available afterwards should further documents need to be translated or an interpreter be required for an online meeting (e.g. when working through a CAPA plan).
The following companies have had longstanding business relationships with us and our founding company AP Fachübersetzungen for many years:
Being understood during a GMP Inspection
Have you also got an upcoming GMP inspection or GMP audit? Please feel free to contact us by phone or e-mail. We work with you to determine your requirements and then prepare a customized offer for you. We would be delighted to count you among our satisfied customers.
Regardless of whether the GMP inspection takes place online or on site - we are at your side to ensure that the involved parties understand each other. First and foremost, this is meant literally, but also in a figurative sense: A pleasant atmosphere for meetings contributes significantly to the success of the GMP inspection or GMP audit. Remote inspections have become increasingly common during the coronavirus pandemic. The focus here is on checking the documentation, which means that the flawless translation of all relevant GMP documents is all the more important. During the remote inspection itself, the GMP inspectors are located in their home country (directly at the seat of their agency or at the corresponding representative of the inspected pharmaceutical company) and join the meeting online. As interpreters or translators, we are usually on site at the pharmaceutical company and accompany you in person.
The tangible added value for the GMP inspection of your pharmaceutical company
We have supervised several dozen American, Belarusian and Russian GMP inspections in recent years and already know many of the inspectors personally. As a result, we are not only familiar with the main areas of focus of their work, but now also know which topics make them "see red." This enables us to give you specific recommendations as to which topics you should prepare particularly thoroughly in order to avoid any complications. We are happy to advise you on this ahead of your GMP inspection by telephone or in person if you wish to meet us in advance.
Queries can be clarified quicker and easier and the remote inspection will run more smoothly if our GMP interpreters and pharmaceutical translators are on site in person - even if the actual GMP inspection takes place remotely and the inspectors are in their home country. Working on site also makes our job easier: Listening is easier and, for example, the operating principle of a complex production line can be better understood and interpreted if you can see it in front of you or talk to the people responsible in person. Whether remote inspections will also be established in the long term, at least in part, is not yet foreseeable. However, you can be sure of one thing: With our linguistic support, your pharmaceutical company's GMP inspection will be a success, regardless of whether it takes place on site or online.