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

New ECA Guide on Integrated Qualification and Validation

Live online conference on 16 and 17 November with Ralf Gengenbach. Presentation of the revised ECA Guide 2.0, which now includes feedback from regulatory authorities, the pharmaceutical industry and suppliers. Time-saving qualification and validation ...

Expert Presentation at COMPAMED: Combination Products – Medical Device Regulations for Market Authorization Holder

November 15, 2021 | 3:00 p.m. | Düsseldorf | Hall 14, Booth 14F22 Which medical device regulations do market authorization holder of integral combination products have to take into account in order to place their product on the European market? Are there any ...

gempex WebSeminar Medical Devices: Product Approval in EU and USA – An Overview

November 30, 2021 | 10-11 a.m. | Medical Devices: Overview of key differences in the approval of a medical device in the EU and USA. Where do combination products and in vitro diagnostics sort in? Register now for free! ...