Stubbs & Hensel Pharma Consulting, LLC Information

In the highly competitive biopharmaceutical marketplace, the need to diversify, innovate, and globalize is paramount. The pressure and cost to get new drug solutions to market is greater than ever. It can stretch your resources to the breaking point or push your staff beyond their capabilities, putting your investment and even your company at risk. In this highly specialized world, you need experts who have years of experience partnering with the FDA and understand all aspects of regulated bioanalysis. A partner who can help you navigate the complex road of drug development and regulatory submissions. You need the experts at Stubbs & Hensel.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.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 over 75 forensic client audits at a major CRO. Our approach, tools, relationships and experience helps our clients successfully mitigate high risk activities.