John Chemelli Consulting, LLC is a manufacturing operations strategy and implementation resource, specializing in regulated products.

We bring a Program Management Focus to drive:

  • Operations Requirements
  • Design Transfer Requirements for Product & Process
  • Operations Implementation Plans
  • Validation Plans

We are well-versed in Design Control Regulations, cGMP, and GAMP®.

A Product Lifecycle Approach for:

  • New Product Development Programs
  • Manufacturing Upgrades or Expansions




Manufacturing Operations' Challenge Areas

Click here to see if some of these issues concern your program


"I have worked with John Chemelli since 2004. I find him to be the rare individual capable of big picture / strategic thinking, with the ability to translate vision into the details needed for execution.” D. Blanchard, Program Manager


Florida Office:
42 Clinton Court N.
Palm Coast, Florida 32137
Phone: 585-733-1165 		New York Office:
525 Nathans Way
Webster, NY 14580
Phone: 585-733-1165