“The expert in asepsis and sterility assurance“

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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

News and Topical

November 2022 Galenisys Newsletter

In our November Newsletter, topics include José Zapata commenting on the “silver lining” recommendation to authorise an adapted Spikevax Covid 19 vaccine. Steve Biddulph reflects on potential cost savings in Packaging whilst Tony Dunford takes a positive slant on the use of anti-depressants. Tony also looks at a recent health scandal that reinforces the need to learn from previous experience. Finally, early in November Galenisys attended the CPHI event in Frankfurt –  a successful opportunity resulting in a number of new tender opportunities.

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

Galenisys USA Inc. 4359, Ravinewood
Dr. Commerce Mi 48382 USA
(248) 676 0521