A-GxP Consulting supports companies in the pharmaceutical industry, medical technology sector and other regulated sectors with complex technical, regulatory and organisational tasks.
We support you in the planning, management and implementation of projects in regulated environments.
Our key areas of focus
Project management for the pharmaceutical industry and medical devices
Support in the area of compliance management
Process optimisation
Lean management
Audit management
QUALITY MANAGEMENT & ISO
We support organisations in the implementation, further development and optimisation of quality management systems.
Our areas of expertise:
ISO 9001:2015
ISO 13485:2016
ISO 17025:2018
Support with audit preparation
Optimisation of existing quality processes
VALIDATION & QUALIFICATION
Our services:
Cleaning validation
Process validation
Development of SWAB techniques
Validation of SWAB techniques
Development of analytical methods
Validation of analytical methods
Qualification of technical installations
Qualification of laboratory equipment
CONTAINER CLOSURE INTEGRITY TEST ING
Our areas of expertise:
CCIT in accordance with USP <1207>
Mass extraction
Vacuum decay
Selection of suitable test methods
Support with the development and validation of methods
AUDITS & PROCESS OPTIMISATION
Our services:
Conducting internal audits
Conducting external audits
Support with audit preparation and follow-up
Lean management
Process optimisation
Support with compliance management