OCTOBER 22-23, 2014: CHEMICAL HERITAGE FOUNDATION CONFERENCE CENTER, PHILADELPHIA
Welcome to Chimera Consulting North America LLC
Chimera Consulting provides technical, regulatory affairs, quality assurance and compliance consulting services to large and small companies that develop, manufacture and market drugs, biologics, medical devices, and in particular combination products such as drug delivery systems and medicated devices.
Michael Gross, Ph.D., RAC is the Principal Consultant of Chimera Consulting. Michael, a recognized expert on combination products, has over 30 years of varied experience in regulatory affairs, quality assurance and compliance roles in the pharmaceutical, biotechnology and medical device industries. He also worked for FDA as a biologics reviewer and establishment inspector.
The Chimera, in Greek mythology, was a fire-breathing beast, part-lion, part-goat and part-snake. For Chimera Consulting, she represents combination products, composed of drugs, biologics and medical devices.
- FDA Guidance - Design Considerations for Devices Intended for Home Use
- Analysis of Guidance - Design Considerations for Devices Intended for Home Use
- FDA Warning Letter Issued for Non-compliance with Combination Product CGMP
- Amgen Warning Letter Analysis