About Us
The help you need, when you need it, from the experts who know how to get it done
Stubbs & Hensel was founded by partners with years of experience in the pharmaceutical and contract research sector, including all aspects of regulated bioanalysis and a broad scope of approvals with the FDA. That real world experience has taught us how to reduce regulatory risk during the drug development phase, and how to work closely with your chosen Bioanalytical CRO as project managers. Specifically, we anticipate, plan and circumvent issues that can delay filing timelines or threaten compliance. We keep your projects on track and on budget with the highest possible standards because we understand what can go wrong and how to help get it right.
Unique tools, unique relationships
Beyond our scientific expertise in LC-MS/MS and immunoanalytical chemistry we bring to every project our unique process and tools. A prime example is Stubbs & Hensel’s successful collaboration with the FDA to create and use the Stubbs & Hensel Electronic Data Audit Protocol, a proprietary approach that has allowed us to perform over75 forensic client audits at a major CRO. We have also developed key relationships with drug development consultants who will move your drug candidate through early development, toxicology testing and into FIH. We have also partnered with scientific consultants in Europe who have expertise in logistics in support of clinical studies, biomarker validation, laboratory qualification and inspection, further mitigating risk and smoothing the path to approval of your biopharmaceutical candidate.
Don’t wait until it is too late
Getting involved with Stubbs & Hensel early in the drug development process is the best way to save time, money and reduce risk when the time comes to prepare your regulatory filing. If you are considering filing and you do not know if you are at risk, we can help. Founded by partners with years of experience handling difficult situations, Stubbs & Hensel provides superior program management, flexible solutions, proactive risk management, and innovative partnering models. Our combination of experience, process, relationships and unique tools creates a powerful force that provides excellence and value to our clients. Find out how our organization can help yours.