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About us

Founded in 2005 by industry veterans, Galenisys stands at the forefront of pharmaceutical excellence, specializing in Quality Systems, Regulatory Compliance, and Project Management. 

Our mission is to ensure the safety and efficacy of pharmaceutical products for patients worldwide, because their well-being is all that matters.

Our team brings decades of hands-on experience to every challenge. We've optimized water systems, streamlined manufacturing processes, and successfully guided countless regulatory submissions.

At Galenisys, we believe in thorough, tailored solutions. Our customers choose Galenisys  for precise and comprehensive solutions across the pharmaceutical value chain.

HERE’S OUR MANAGEMENT TEAM

Richard Van Duyse

Technical Director

Specialized in project and operational management, facility, equipment and utility design, start-ups, and technology transfers. Richard holds a Bachelor of Applied Science degree (B.Sc.).

Kenneth Feld

President, Galenisys USA, Inc

Ken Feld is a Chemist from the University of Michigan with 30 years’ experience in the pharmaceutical industry, specializing in process development, product development, and technical operations.  

Steve Biddulph

President

A Microbiologist and Fellow of the Royal Society of Biology, with in depth experience of pharmaceutical processes, equipment, facilities and utilities, expertise in QMS and aseptic manufacturing & control. He is  Managing Director of Galenisys.

Hary Biddulph

Director Business Intelligence, Client Relations and Co-Managing Partner at Galenisys

Formerly in charge of mRNA vaccine strategy at Sanofi, with extensive experience in business intelligence, strategic analysis, and client relations within the pharma and healthcare sectors.

Julio Varela

Industrial Director

Pharmacist and Doctor in Applied Organic Chemistry, with 37 years of experience in the bio-pharmaceutical industry and has held positions as Site Director for several sites across the world.

Terry Simmons

Director Galenisys England & Senior Associate

Terry Simmons is a Chemist with 35 years experience in the Bio-Pharmaceutical Industry. He is a Senior Industrial Operations Executive, holding positions in Supply Chain, Quality and Manufacturing.

Tony Dunford

Business Oversight Director

Tony Dunford is a Chemical Engineer with 50 years’ experience in the pharmaceutical industry, specializing in production site management, supply chains, and capital projects for API manufacture, filling & packaging, laboratories, and warehousing.

 

Support Functions


Therese Limare

Cyprien de Barros (IT)



 

Regulatory and Industrial Experts


Paul Aboody : Sterility Assurance and Quality Systems

Joe Day : Sterility Assurance & Quality Systems

Christophe Priou : Quality Systems

Yves Lambert : Manufacturing, & Capital Projects

Jean-Jacques Richard : Quality Control, & Industrial Operations

Cidalia Vitorino : Regulatory Affairs, & Quality Systems

Gérard Philippot : Capital projects

Mohamed Said Masrar : Regulatory & Business development

 

Regulatory and Industrial Experts


Anne Alcock : Quality Systems & Capital Projects

Laurent Caburet : Regulatory Affairs & Manufacturing

Matthew Hulbert : Sterility Assurance, Quality Systems & Manufacturing

Marc Pocquet : Technology Transfer &  Manufacturing

José Zapata : Quality Assistance & Production

John White : Production

Frank Fabbro : Quality Assistance

John Seagrief : Production & Quality Assistance