Accelerating Timelines
Maximizing Cost Efficiency
You’ve got the science. We help you turn it into a regulatory strategy the FDA says yes to so you can get to the clinic faster, with runway left to prove your science works.
The Heavy Weight of Wearing Every Hat
Right now, you are tackling endless obstacles that need to be solved.
You know that a major failure at any one of them could sink your company.
You’re managing vendors, navigating complex trial designs, and worrying about regulatory shifts.
And you are doing it all with just a fraction of the headcount of big pharma.
It feels like there is never enough time to do what you really want: focus on your science.
Meet Your Drug Development Co-Pilots
You need smart systems, not big systems.
Led by Matthew Barnes and Sheila Mathias, PhD, Praecur Consulting Services bridges the gap between your brilliant science and your operational reality.
We take the heavy burden of vendor management, quality control, and regulatory strategy entirely off your shoulders.
You get to stay focused on the science, while we handle the seamless transition from planning to execution.
Meet Your Drug Development Co-Pilots
Stop obsessing over the runway. We keep your development moving forward while protecting your capital.
We build lean, efficient systems that manage your vendors tightly and prevent costly mid-trial delays.
Build Quality Into Your Trial Design
Never worry about failing a surprise audit or re-doing costly work.
We specialize in Quality by Design (QbD) implementation aligned with ICH E6(R3) and E8(R1) guidelines.
We build compliance into your clinical foundation from day one, so you are always inspection-ready.
Navigate Global Regulations with Confidence
Don't let regulatory red tape slow down your path to market.
We craft comprehensive regulatory strategies that satisfy the FDA, Health Canada, MHRA, and EMA.
No matter where you plan to launch, we ensure your data meets the exact standards reviewers demand.
Ready to Move your Therapy Forward?
Let’s build a clinical strategy that protects your capital and gets your therapy to the patients who need it most.
Still Deciding? Start Here.
Still Deciding? Start Here.
What Stage company do you work with?
We work with small and mid-sized biotechs at every stage, from pre-clinical through phase 3.
What Happens on the free Strategy Call?
We’ll look at where your program stands today, identify any regulatory or operational risks, and give you a clear picture of what is needed to advance your program to the next phase of development.
At what stage should we bring you in?
The earlier, the better. Bringing us in during the pre-clinical or early planning phases helps you avoid costly mistakes and ensures a smooth path to FDA or EMA approval.
We’re a small team. Can we afford outside help?
Most Founders find that one avoided misstep saves far more time and cost by getting it right the first time. We’ll be upfront about our hourly rates and what makes sense for your stage and budget