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Consulting Team

Phil Triolo, PhD, RAC     
- Founder, Senior Consultant

Phil Triolo has over 28 years of hands-on industrial experience in the design, development, evaluation, and approval of medical products.  He is co-inventor of 8 design patents for medical products ranging from bioluminescent detectors to drug delivery catheters, demonstrating an ability to make significant, original  contributions to the development of a wide array of  medical devices and diagnostic products.
Medical product development is a regulated process requiring proactive planning.  Phil has efficiently integrated documentation and submission requirements in product development activities to assure early submissions, short review times, and accelerated market introductions.  All of the regulatory submissions he has authored have been cleared in times shorter than FDA review averages.
A Certified Quality Auditor (CQA, ASQ) and Certified (RAC) by the Regulatory Affairs Professional Society (RAPS) in FDA drug, device, and biologics regulations, Phil is a member of the Society for Biomaterials,  American Society for Quality (ASQ), Association for the Advancement of Medical Instrumentation (AAMI), and Tau Beta Pi (Engineering Honor Society).
He is past President of the Intermountain Biomedical Association, current Chair of the University of Utah Department of Bioengineering's Industrial Advisory Board, and was recently inducted as a Fellow of the American Institute of Medical and Biological Engineering (AIMBE).
Phil holds M.S. and Ph.D. Degrees in Bioengineering from the University of Utah where he was a Research Fellow, and a B.S. Degree in Biomedical Engineering awarded cum laude from Rensselaer Polytechnic Institute.  His master's thesis, Surface Modification and Characterization of Commonly Used Catheter Materials was conducted under the direction of Prof. Joe Andrade, and his doctoral dissertation, Release of Albumin from Biodegradable Poly(l-lactic acid) Matrices under the direction of Profs. Sung Wan Kim in the United States and Jan Feijen in the Netherlands.

Ryan O'Callaghan, MBA, RAC
- Associate, Electronic Submissions & DMF Specialist

Ryan O'Callaghan is certified (RAC) by the Regulatory Affairs Professional Society (RAPS) in FDA drug, device, and biologics regulations.  He holds an MBA and an MS in Bioengineering with a focus in medical device development from the University of Utah and has been involved with multiple early stage medical technologies in regulatory, research, engineering, management and fundraising capacities.

Ryan specializes in the preparation and submission of the following types of electronic submissions:
  •  eCTD  -  Drug master file (DMF) submissions to US FDA
  •  "Non-eCTD Electronic-only"  -  Drug master file (DMF) submissions to Health Canada
  • eCopy  -  Medical device submissions to US FDA

Christopher Clemens
- Associate, Regulatory and Clinical Affairs Specialist

Christopher Clemens is a research scientist with expertise in the management and performance of preclinical oncology studies, including efficacy, toxicology and PK. He is proficient in immunological techniques, mammalian cell transfection, immunoassay and bioassay methods, tissue culture and microbiology techniques. Christopher is also the co-author of over 35 publications and 8 U.S. patents.