QRM Kickstarter for Biotech

Spot & fix quality risks in 30 days. Boston-NH specialists.

The Problem

  • Biotech startups face unpredictable risks- equipment failures, assay drift, supply chain hiccups
  • Without a structured approach, teams waste time firefighting instead of preventing issues
  • Missed risks delay launches, burn cash, and erode investor confidence

Our Solution

  • Apply ICH Q9 QRM in four clear, practical steps
  • Use lightweight, scalable tools- like one-page risk registers and heat maps- that fit lean teams
  • Build a proactive, risk-smart culture that speeds inovation and satisfies regulators

Why Us?

  • We translate regulatory jargon into clear, everyday langauge your team understands
  • We run fast, inclusive workshops that produce action-ready risk registers in a single session
  • Our approach blends compliance and efficiency- helping you mangage risk without slowing science