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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
July 2022 Galenisys Newsletter
In our July Newsletter, Steve Biddulph looks at Rapid Microbiological Methods as part of Contamination Risks and Controls whilst Jose Zapata reflects on Data Integrity – currently a focus area for Regulatory Authorities. There is also further information on building new a new CMC section for an NDA and finally some details on the growing use of Injectable Cosmetics.
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….
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