“The expert in asepsis and sterility assurance“

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Galenisys

Welcome to Galenisys – pharmaceutical consultants specialising in Quality Systems, Regulatory Compliance and Project Management. We offer healthcare and biomedical consulting services to clients at both corporate and manufacturing level across Europe and the US, throughout Asia and Latin America and in emerging markets in the Middle East, Turkey and Africa.

We believe in putting you first, getting the basics right (or sometimes simply getting back to basics) and working to help you become – and stay – compliant with the latest FDA and EMA regulations.

In addition, we also offer comprehensive training to your staff and new ways of improving your business performance.

We look forward to working with you to help take your business forward by improving compliance and efficiency, implementing new production strategies and ensuring growth.

Steve Biddulph
Director

News and Topical

Governance in the Health Industries

Drawing on his long experience as a senior QA executive in various companies, Steve Biddulph connects Quality Assurance & Good Governance, and suggests how the former can help the latter. A future article will focus on Business Oversight.

Poor corporate governance and oversight are frequently cited factors in Observations of poor quality and non-compliances, by Regulatory agencies, particularly FDA investigators following (GMP, GCP and PAI) inspections.

Official enquiries into major tragedies in other industries often mention poor corporate governance and oversight. What is meant by this?

Core expertise

Aseptic Sterility Assurance

We have experts who are recognised throughout the industry and who have worked at both shop floor and strategic levels to ensure that sterile product quality is assured….

Qualification and Validation

If your infrastructure doesn’t meet regulatory standards, or isn’t robustly validated at each stage, compliance will become more difficult – and take longer…

Quality Systems

If you need world-class quality systems in place at your facility, Galenisys can help you design and implement robust quality systems that meet the latest US and EU standards…

Regulatory Compliance

If you want to make certain your facilities and procedures are compliant with regulations, ask Galenisys to perform a compliance audit…

Areas of specialisation

Capital Investment Projects

Operating in the Emerging Markets, you may soon need to increase your production capacity, enlarge your facility or plan a new green field site construction…

Pharmaceutical Consultants

Galenisys is a top-ranking pharmaceutical consultancy with extensive experience working with blue chip pharmaceutical manufacturers in North America and Europe…

Emerging Markets

Galenisys Consultants have practical experience in Emerging Markets. They have held positions in Industrial Operations and management of quality structures….


Galenisys 11, rue Notre Dame de
Nazareth 75003 Paris – France
+33 (0)1 45554414
info@galenisys-pc.com

Galenisys USA Inc. 4359, Ravinewood
Dr. Commerce Mi 48382 USA
(248) 676 0521
info@galenisys-pc.com