Accelerating FDA approval to unlock $1M in daily revenue

12 March 2025 — 1 min read

Healthcare & Pharmaceuticals

Breakthrough Imperatives

A biopharmaceutical company faced an impossible FDA submission deadline. Skeptical teams, weighed down by distrust and limiting beliefs, transformed through breakthrough performance methodology—delivering the submission 45 days early, saving $1M per day and earning a unanimous FDA approval.

Outcome 1: Reduced the drug submission to the FDA by 45 days that original timeline
Outcome 2: Saved an estimated $1 million (USD) a day
Outcome 3: Achieved FDA approval and launch of the drug sooner than they believed they could

The challenge

In the highly regulated and competitive biopharmaceutical industry, speed to market is critical—not just for business success but for the patients who depend on new treatments. With millions of dollars and countless lives at stake, the client turned to us to drive a fundamental transformation in how they worked, collaborated and delivered results.

A biopharmaceutical company developing a breakthrough drug for motor function impairment faced a major hurdle—it was far behind schedule. A cross-functional team consisting of leaders from testing to quality control doubted they could meet the CEO’s aggressive deadlines, and were already six months behind.

The approach

Together, we helped them break free from existing assumptions, transforming scepticism into ownership. We reimagined their strategies and rallied behind a bold new vision: One Team, One Dream, The Unreachable is Our Routine.

With this new unified approach, our client set a more ambitious goal—delivering the drug 45 days ahead of schedule. Through enhanced transparency, faster decision-making and a culture of true collaboration, we turned what seemed like an impossible deadline into a resounding success.

The value delivered

Our client submitted the drug to the FDA, beating the original deadline by six weeks and saving an estimated $1 million per day. They also delivered a high-quality submission, earning a unanimous 12-0 approval recommendation from an independent panel—an impressive industry feat. Most importantly, our client brought a life-changing drug to market faster. Beyond this success, they applied their newfound approach to future projects, creating lasting impact across the company. This breakthrough not only met but exceeded expectations, proving that bold goals are achievable with the right mindset and strategy.