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

China's Biotechnology Sector in Transition - How a Country Confidently Masters Rising Compliance and Technology Requirements

New technical article from gempex --- From contract manufacturer to producer of its own pipeline products --- GMP compliance, development of modern pharmaceuticals, technological advancements, audits, potential for mutual success ...

Root Cause Analysis and GMP - Fundamentals and Overview

Root Cause Analysis in GMP quality management systems --- Focus on the human error --- GMP expertise from gempex in a training ...

Validation of Excel Spreadsheets to Enhance Resources: IT Validation, Documentation, Compliance Testing, and Data Integrity

With the Excel applications now GxP-compliant validated, Axolabs fully meets the regulatory requirements for data integrity and compliance. Complex analytical evaluations can be prepared in a standardized manner, performed under controlled conditions, and ...