As the Principal Consultant, I offer biopharmaceutical and medical device clients an array of regulatory, clinical, quality and legal services to meet your project goals.   These include:

  • Premarket support as an active new product development team member (design control and Quality by Design methodologies)
  • Preparation of U.S. and international regulatory strategies to expedite process of bringing investigational products from the lab to the market.
  • "hands on" clinical research and operations support
  • Regulatory applications drafting and submission services, including 



Southborough, MA, USA   |  +1.617.633.6462  |

  • Medical device U.S. FDA "510(k)" , EU MDD "Tech Files"  and globally accepted Summary of Technical Documentation (STED) applications.
  • Investigational exemptions (INDs and IDEs), and marketing approval applications (PMAs, NDAs and BLAs). 
  • Quality System design and implementation per U.S. drug and medical device regulations (21 CFR Part 211, Part 820) and international standards (ISO 13485)

Robert J Michalik, J.D., RAC

Founder & Principal Consultant