Our Services
Based on more than 25 years experience in the life sciece industry we support our clients with our broad QA expertise and operational support in their challenges along the life cycle of their products and are a reliable partner in all aspects of quality.
Quality Vision and Strategy
We believe that the optimal quality approach is balanced between science understanding, risk management and compliance. In alignment with these three aspects we developed strategic drivers and proposals how to execute.
In all cases we make sure that strategic drivers are tailored to your needs and your long term goals and turned into actionable projects.
Quality Management System
We design a procedural landscape to ensure all GMP and compliance activities are covered.
We enhance the modular design of your Quality Management System and we inbuild proactive risk management as a standard part of your procedures to keep processes efficient.
Quality Culture
We help you to understand what is beyond GMP compliance. We evaluate and influence your quality culture to enhance the right behavior - fostering “we do what we say, we say what we do - we do even when nobody is watching”.
You will experience a strong correlation between your existing Quality Culture and the chosen design of your Quality Management System.
GMP Readiness Program
Our end to end approach includes a portfolio of a series of readiness programs.
Programs from Inspection Readiness and Campaign Readiness to PPQ Readiness will further tailored your needs.
The services start with the correct design of a readiness program and ends with the support of its execution.
Validation for Biologics and APIs
The combination of science understanding and GMP regulations allows us to have a series of validation protocols ready for your process and cleaning validation.
We have more than 25 year experience in biologics and protein science.
Based on more than 25 years experience in the life sciece industry we support our clients with our broad QA expertise and operational support in their challenges along the life cycle of their products and are a reliable partner in all aspects of quality.
Ad Interim Quality Management
We take over roles in management and leadership based on your needs.
The owner of GMPLICITY Consulting GmbH has more than 25 year experience in the life science industry exclusively in quality positions with increasing responsibility including being team manager, site quality head and chief quality officer.
Due Diligence and Audit
We do your internal assessments and your supplier audits.
The owner of GMPLICITY Consulting GmbH hosted more than 100 customer and corporate audits and has experience in 16 Health Authorities inspection, while 13 of them he hosted himself. He understand the current approach to GMP and compliance.
Product Release
We release your products based on your release criteria .
The owner of GMPLICITY Consulting GmbH has been a responsible person for SWISSMEDIC during 9 years and register person for TGA for 4 years. He is very well known and respected by SWISSMEDIC.
GMP Training
You train a dog, but you educate a child.
We develop for you training slides for specific GMP topics and train your people at your site.
GMP Documentation
We support you in your GMP Documentation including deviations, changes, SOPs and validation reports.
Wil (SG) & Gampel (VS) Switzerland Narbonne France
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