GMP Compliance
Commissioning & Qualification
IT Validation
GMP Routine Support

 

As a GMP expert with an international presence, gempex in addition to meeting the applicable quality standards also provides the required guarantee regarding all compliance matters. gempex enjoys the trust of its customers. That is because gempex understands situations and problems, makes informed and pragmatic recommendations and assists customers with implementation. 

gempex – GMP Consulting & Execution

Change Control and GMP Compliance

In order to meet regulatory requirements even after changes in the manufacturing process of active ingredients or pharmaceutical and biotechnological products and thus to maintain the necessary GMP compliance, an effective change control system is required. ...

EU MDR: Transitional period ends on May 26, 2021

The transitional period for the new EU Medical Device Regulation (MDR) ends on 26th May. It will bring significant changes for medical device manufacturers launching their products on the European market. ...

Everyday Work in GMP Projects During the Time of the Corona Pandemic

gempex remains fully available to you - in Germany, Switzerland and China ...