GxP Consulting
As GxP consulting experts, we help pharmaceutical companies reliably align their processes with regulatory requirements. With us, you pass audits with confidence and bring your products to market safely.
Clients who trust us
Our GxP consulting services
Continuous Compliance
Regulations, software, auditor expectations and many other factors change regularly in the pharmaceutical environment. We help you keep the effort of change to a minimum and stay compliant.
Project Management
Project management in a GxP environment is complex – we make it simpler for you. We take over full project control and ensure your projects are delivered on time, cost-efficiently and compliantly.
Regulatory Affairs
Our Regulatory Affairs service ensures that your processes and documentation meet the applicable quality standards to secure approval of your products. We help you comply with GxP guidelines to safeguard the integrity and safety of your medicinal products, medical devices or diagnostics.
Qpliance Academy
The Qpliance Academy offers practical training on GxP, communication and compliance – as standard courses or tailored to your organisation.
QMS Consulting
We establish and optimise effective quality management systems (QMS). We advise you from concept to successful implementation to ensure compliance and improve your processes for the long term.
Compliant Software Configuration Assessment
Together with you, we develop a user management concept that covers all regulatory requirements while giving employees the freedom they need to work productively and efficiently.
Frequently asked questions about
GxP consulting at Qpliance
In a fast-changing digital world, it is difficult to keep every ongoing process 100% compliant. So that you don't get a rude awakening just before your next audit, we offer continuous review of your processes. This keeps you up to date with changing regulations, lets you go into your next audit with confidence and ultimately boosts your productivity without compromising quality.
Our GxP consulting services include Continuous Compliance, Project Management, Regulatory Affairs, QMS Consulting, Compliant Software Configuration Assessment and our Qpliance Academy.
Our GxP consulting covers the applicable regulatory requirements of the EU GMP Guidelines, ISPE GAMP® 5 Second Edition, 21 CFR Part 11 and many more.
In general, consulting refers to internal or external advice given to organisations on a range of topics. At Qpliance, we understand consulting as helping an organisation or its departments find solutions to existing or emerging problems – always with the aim of optimising processes and structures.
The Qpliance Academy brings together our training and professional development offering. Here you will find white papers, flyers and on-demand courses, and you can easily book individual training sessions. Get in touch!
Delivering projects takes time and money. That's why Qpliance supports you through planning, execution and completion with our project management service. Whether you need full project control including resource and supplier management, or support in individual areas only – just get in touch!
A QMS (quality management system) is a system of SOPs (standard operating procedures) and other documents that ensures an organisation runs smoothly. We advise you on designing and implementing a QMS, as well as on backup & recovery strategies, to make your processes compliant and sustainable.
