Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Gil Salud, MS joined the Biologics Consulting Group, Inc. (BCG) as a Senior Consultant on April 1, 2008.

Gil has over 14 years of industry experience in the technical, quality and regulatory requirements of biologic, small molecule, and medical device product manufacturing and commercialization.

His technical and practical experience has afforded him varied employment opportunities within the pharmaceutical, biotechnology and device industry. He has managed projects that support the manufacture of pre and post licensure of products. Gil has managed capacity expansion projects for small organizations to multinational firms. While at FDA, he reviewed multiple BLA, NDA, PMA, and 510K submissions. He has also served as lead investigator on foreign and domestic audits of pre and post marketed products. His specialties include product and process qualification, aseptic manufacturing, robotics and computer controls, facilities and equipment qualification, managing Architectural and Engineering projects, pre and post approval quality audits, QSR, GMP, and GLP

Gil's most recent position was at the FDA with CDER at the Office of Compliance where he held the position of Team Leader of the Biotech Manufacturing Team, overseeing the manufacturing regulatory review of BLA and sBLA (PAS, CBE, and AR) applications and conducting pre and post approval inspections. While at CDER he was the consult reviewer for CDRH combination products. Gil has served on several FDA guidance committees. He has also served as the manufacturing process technical liaisons between FDAs Office of Biotech Products and Office of Compliance. He was CDER OC's subject matter expert and the point person for the assessment of new and modified manufacturing facilities.

During his employment at the FDA, Gil was also at CDRH at the Office of Compliance Division of Enforcement A as a Sr Compliance Officer. As a compliance officer, he reviewed medical device PMA and 510K applications. He has written several Untitled Letters and Warning Letters to violators of the Food and Drug statutes and provided documentation to support medical device recalls.

Prior to his tenure at the FDA, Gil held several project management positions with several contracting and consulting companies. He has managed multiple capacity expansion projects supporting API and finished product manufacturing. He has technical and practical experience in solids, semi solids, and biotechnology product manufacturing. His industry experience include working for Johnson and Johnson, Abgenix, Genentech, Alza Corporation, Bayer, Hoechst-Celanese, LXR Biotechnology, Shacklee Corporation, Roche, Oread Labs, B. Braun, Corporation, Amgen, Penta Biotechnology, Baxter, and Inhale Therapeutics

Gil received his B.S. in Biology and Chemistry from San Francisco State University, and his Masters in Chemical Engineering from San Francisco State University.

As a Senior Consultant with Biologics Consulting Group, Gil will utilize his technical and professional experience in quality and regulatory affairs to assist clients with:

• CMC, PMA,510K development planning for biologic, small molecule drugs, and medical device
  
• Strategizing, preparation and critical review of all types of CMC, PMA, 510K related regulatory documents
  
• Pre and Post submission support for Pharmaceutical, Biotechnology and Medical Device Products
  
• Third party evaluation and audits for suppliers and CMOs
  
• Preparations for FDA meetings and audits
  
• Assist with investigation and resolution of FDA compliance issues
  
• Provide strategic support in FDA interactions
  
• Provide analysis and strategic planning for capacity expansion projects
  
• Provide cGMP training
  

View Mr. Salud's Curriculum Vitae...

Page Updated August 21, 2008