Developing A Control Strategy And Minimizing Risk In Phase I Injectable Drug Development

By Sitav Elturan, Singota Solutions

Not long ago, in labs everywhere, drug developers often found themselves playing a precarious game of “let’s hope this doesn’t go wrong.” Spoiler: hope is not a process control. In early-phase injectable drug development, success doesn’t come from mixing molecules and crossing your fingers — it comes from designing a deliberate, intelligent framework that can anticipate problems before they derail your molecule’s future.

That’s where control strategies enter the picture. Think of them as the seatbelt, GPS, and crash-avoidance system guiding the journey from preclinical chaos to Phase I clarity. A well-crafted control strategy isn’t just about defense — it’s the proactive playbook that enables efficient, high-quality, and regulatory-ready operations long before the first dose ever reaches a patient.

Investing early in the right controls not only minimizes risks but also accelerates timelines, streamlines regulatory interactions, and builds trust across the ecosystem — from partners and sponsors to regulators and patients. In a field where every milestone matters, control strategies transform uncertainty into direction and risk into resilience.

So whether you’re setting foot on this path for the first time or revisiting your approach to make it sharper, buckle up. This isn’t a paper exercise; it’s the blueprint for success in the most critical stage of your drug’s life cycle.