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IPS

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Russ Somma, Ph.D.

Pharmaceutical Technologist

OSD / Containment Expert

Areas of Expertise

  • Solid Dosage Forms 
  • Liquids, Semi-solids
  • Advanced Drug Delivery
  • Osmotic Dosage Forms
  • Medical Devices 
  • Report Preparation 

 

Our Mission? To assist clients with strategic and tactical implementation and to bring their products to peak sales rapidly to fully realize the potential of the product’s life cycle. Most importantly, you need to know what you do not know.

- Russ Somma
Pharmaceutical Technologist

Dr. Somma has more than three decades of experience working in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management. He has a particular technical interest in the area of solid dosage forms and the physical pharmacy associated with them.  Employed by an owner for the majority of his career, Dr. Somma has held leadership positions with direct responsibility for senior staff, including international, as well as cross- and multi-functional teams. He has provided technical development and life cycle management support for a variety of oral solid dosage, novel formulations and therapeutic groups.  Additionally, he has served as an invited investigator trainer and liaison for the FDA on various projects and initiatives, affording a unique perspective within Pharmaceutical Regulatory Affairs.

At SommaTech, Dr. Somma’s focus is on pharmaceutical technology and helping clients achieve their FDA regulated product goals for a fast submission and seamless approval, as well as assuring a cost effective product and secure supply chain.  He has a strong background in implementation of SUPAC IR/MR equipment guidance with society associates and colleagues within FDA/CDER, and shares this expertise with clients. 

Considered a subject matter expert in technology transfer and Quality by Design, Dr. Somma has been a welcomed keynote speaker and presenter at many association meetings and conferences. He has written and co-authored numerous articles, technical papers and studies in peer reviewed journal and publications such as Pharmaceutical Engineering, Journal of Pharmaceutical Innovation and, most recently, Pharmaceutical Executive. He also contributes to the IPS Oral Solid Dosage Technology Tour during one of the industry’s largest biopharmaceutical tradeshows, Interphex. 

  • p. 732-748-1990

Recent Projects

  • Patent Litigation 
  • Surgical Implant Combo Product
  • Roller Compaction Process
  • Ion Exchange Resin Dev.
  • Fixed Combination Dev.
  • Product Due Diligence
  • Clinical Dosage Form Dev.
  • Production Troubleshooting
  • IND CMC Updates
  • sNDA CMC Preparation
  • SOP Creation