“The expert in asepsis and sterility assurance“

About us

About us

Galenisys Pharmaceutical Consultants are a team of highly skilled, qualified professionals with a wealth of experience in the pharmaceutical, biotechnology and related industries in North America, Europe and Emerging markets.

We bring quality, technical and management expertise to help clients around the world achieve their business objectives and enhance the effectiveness and efficiency of their production processes within regulated environments.

Working alongside us are the Galenisys Associates – experienced professionals we can call on to help us complete successful projects in all fields, from product formulation to major infrastructure and engineering projects.

A global consultancy firm

Galenisys USA Inc was created in 2017 to provide the best service to the US based companies.

Galenisys has a rich experience working with many clients in the USA on FDA readiness and remediation programmes, particularly in the areas of sterile products and asepsis.

Galenisys also works with clients around the world not only in the USA but also have experience interacting with regulatory authorities in Australia, Japan and Latin America – as well as special expertise dealing with regulatory bodies in the USA, UK and France.

With Galenisys Emerging Markets, we’re adapting this expertise to pharmaceutical companies operating in the developing world. Please see our Galenisys Emerging Markets section to learn more about how we’re bringing world-class pharmaceutical expertise to Africa, the Middle East Asia and Latin America.

Our mission

  • Aseptic Sterility Assurance
  • Quality Systems and Quality Organisation
  • Quality and Regulatory Management/Inspection Preparation
  • Auditing for Compliance to Regulatory Requirements
  • Troubleshooting Quality Issues
  • Qualification and Validation
  • Capital Project Management
  • Training and Development
  • Business Excellence

References Galenisys

Eric Gruber

Financial & Emerging Markets Director, Galenisys

Steve Biddulph

Managing Director, Galenisys

Terry Simmons  

Technical Director, Galenisys

Kenneth Feld  

President, Galenisys USA, Inc

Tel : +33 (0)6 80 96 82 90

Mail : eric.gruber@galenisys-pc.com

Tel : +33 (0)6 32 32 99 27

Mail : steve.biddulph@galenisys-pc.com

Tel : +44 7736 116396

Mail : terry.simmons@galenisys-pc.com

Tel : (248) 676 0521 (office) , (724) 557 4415 (cell)

Mail : ken.feld@galenisys-pc.com

HERE’S OUR MANAGEMENT TEAM

E.Gruber  PhD, MBA-MAE, IPIP 

Eric Gruber is a Pharmacist (Paris V & XI ) with 45 years’ experience in the Bio-Pharmaceutical Industry, particularly in the areas of Industrial Operations, Capital Projects and Industrial Excellence.

Eric has worked for Rhone-Poulenc, RP-Rorer, Aventis, and Sanofi in France and overseas and has positions as Site Director in France for Rhône Poulenc Santé and as Vice-President of Industrial Operations for Aventis Intercontinental zone (Latin America/Africa/Middle East and Asia)

S.J. Biddulph FRSB, MSFB, MIQA  Managing Director

Steve Biddulph is a Microbiologist with 50 years experience in the Bio-Pharmaceutical Industry, particularly in the areas of sterile product manufacture and control, Quality Systems and FDA and EMA requirements for Research, Development, Manufacture, Control and Post Marketing Surveillance.

Steve has worked for Rhone-Poulenc, Aventis, Pasteur and Sanofi in the UK and France and has held positions as Manufacturing Site Director of Quality and as Vice-President of Global Quality.

T. Simmons BSc Chemistry

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

Terry has worked for R.P.R., Aventis, and Sanofi where he has led Major Capital investment Projects, in manufacturing, packaging, and the supply chain. In addition, Terry led the team concerned with new Technology and Industrial Development.

K.Feld PhD

Ken Feld is a Chemist from the university of Michigan with 30 years experience in the Pharmaceutical industry, particularly in process , product development and technical operations

He worked in the USA for Rhone Poulenc Rorer, Appolon, Dermik, Omnicare, Patheon and finally Cephalon as Vice President Development.

T.Dunford BSc.

Tony Dunford is a Chemical Engineer with 50 years’ experience in the Pharmaceutical Industry, particularly in managing production sites, supply chains, and capital projects for API manufacture, filling & packaging, laboratories & warehousing.

This experience was gained in positions in UK, France, Switzerland, The Netherlands, and Australia; with operational secondments in Japan & Spain. He became a Member of CIPS, qualified as an Assessor of Pharma Quality Systems; and has lectured at De Montfort & Derby Universities.

Tel : +33 (0) 7 89 70 13 48

Mail : tony.dunford@galenisys-pc.com

J.Varela QF, PhD

Julio Varela is a pharmacist (Montevideo/Uruguay) and a doctor in applied organic chemistry from the university Louis Pasteur in France with 37 years of experience in  the Bio-Pharmaceutical Industry, particularly in the areas of Industrial Operations, Capital Projects and Industrial Excellence.

Julio has worked for Rhone Poulenc Rorer, Aventis and Sanofi- Aventis where he supervised several engineering projects and occupied the position of production director in Spain and industrial head in Indonesia, Egypt, Algeria and Colombia

Tel : +33 (0)6 78 49 66 49

Mail : julio.varela@galenisys-pc.com

J. Zapata. PhD

José Zapata is a Pharmacist (Madrid), with 30 years’ experience in the Pharmaceutical industry, particularly in Quality and in Industrial Operations working within FDA and EMA environments, especially for sterile production.

José has worked for Loreal and Rovi in Spain, in positions of Quality, Quality Head for the group and Industrial Director managing three Pharmaceutical plants.

Tel: +34 670 560 512

Mail : jose.zapata@galenisys-pc.com

Support Functions

Therese Limare
Colin Washer
Howard Enterprises

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

 

Regulatory and Industrial Experts

Fardjallah Belherir  
Manufacturing and Aseptic Behaviour, QMS & Compliance
Julio Varela   
Industrial Operations
Gérard Philippot  
Capital projects
Mohamed Said Masrar  
Regulatory & Business development


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