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

US FDA is Coming: Inspection Readiness for the Pharmaceutical Manufacturer

The periodical inspection of compliance is a central requirement of the GxP regulations. At PharmaTechnica, Dr. Ralf Aubeck reports on the importance of inspection readiness for pharmaceutical manufacturers and how to face US FDA audits calmly. ...

MDSAP - Medical Device Single Audit Program - an Elegant Way!

Great savings potential for internationally operating medical device companies -- - Harmonized QMS certification for medical device manufacturers in the export markets AUS, BRA, CAN, JAP, USA -- lean and efficient ...

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

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