Keeping CMC Timelines on Track When It Matters Most
CMC execution · Lean teams · Regulatory-critical milestones
How a clinical-stage team brought discipline and control to CMC delivery under fixed regulatory timelines.

Context

A lean clinical-stage team advancing a Phase 2 program faced mounting pressure to deliver CMC components tied to fixed regulatory milestones. The science was solid, but execution systems had not kept pace with the stakes.

Timelines were compressed. Bandwidth was limited. The cost of delay was real.

Where Execution Risk Was Emerging

As CMC activity intensified, risk showed up in the seams:

  • CMC and clinical timelines were tracked separately, with no unified view
  • Meetings generated discussion but little durable follow-through
  • Dependencies were understood informally, not operationally
  • Complex CMC topics lacked structured forums for decision-making
The risk was not collapse. It was gradual drift that turns into last-minute fire drills.

What We Did

We helped the team put execution structure in place that matched the moment.

The work focused on:

  • Building live, integrated timelines aligned across CMC, regulatory, and clinical
  • Standardizing meeting documentation with clear actions and ownership
  • Facilitating quarterly CMC deep dives to surface risks and resolve blockers
  • Embedding simple routines to keep decisions moving and handoffs clean
This wasn’t added process. It was execution discipline designed for lean teams.

What Changed

  • Teams operated from a shared roadmap instead of disconnected trackers
  • Deliverables and follow-ups stopped falling through the cracks
  • Deep-dive sessions surfaced risks early and clarified trade-offs
  • Execution stayed aligned with regulatory expectations as timelines tightened
  • Result: The team delivered the CMC components required to support CTA submissions and Phase 2 progression—without scrambling and without surprises

Why This Held

  • Accountability was visible and trackable
  • Meetings became decision forums, not status updates
  • Tools reinforced behavior rather than bureaucracy
  • Timelines were used for planning, not reporting

The team gained control, not just visibility.

Where This Works Best

  • Submission milestones are approaching and the CMC path feels unclear
  • Team capacity is tight but timelines cannot move
  • Everyone is working, but no one owns the full execution picture
  • Leadership needs confidence that commitments will hold
This case study reflects an anonymized CMC-focused engagement. Details have been generalized to protect confidentiality.