Once identified, your target compound or therapy will need to be fully validated using in-vitro and in-vivo testing techniques, and our experts will help you determine the most appropriate model.
We’ll work with you to identify, outline and plan appropriate in vitro and in vivo studies to address pharmacology, safety and toxicology, keeping in mind that in vitro data can deliver useful information downstream in the development process. We can also help with the development of non-clinical safety programs designed specifically for advanced/cell and gene therapy products, involving a mix of in vitro and in vivo assessments.
Finding the right model for you
Many innovative medicines require a tailored non-clinical safety assessment program. Our specialists have considerable experience in translating treatment concepts into product development programs that are accepted by regulatory authorities. We are solution focused, cost conscious and thrive on solving problems.
In addition to our depth of experience across multiple different product types, we have a large pool of experienced experts to contribute to client projects.
Get In Touch
Steering your product strategyWherever you are on your journey as a biotech – whether you’re still forming your team or seeking funding or putting together marketing authorization submissions – we’ll apply our deep industry and regulatory expertise to optimize your opportunity. We can help you across every stage of your product and business lifecycle, spanning:
Regulatory Agency Interactions and Clinical Trials
Non-Clinical and Quality
Establishing a Strategy
Due Diligence and Partnering
Insights HubSharing insights, questioning norms, asking the right questions - we'll never lose sight of what you're striving for. Our insight and expertise will help you bring the most innovative therapies within reach of patients around the world.
Planning for CBER and EMA success with cell and gene therapy
By Cori Gorman, Ph.D. The fields of cell and gene therapy are enormously promising while
News & Events
Start a conversation today
If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.