Safety Assessment

Get In Touch

We’ll help you develop a non-clinical safety assessment program that’s scientifically justified and focused, and which maximizes the chance of regulatory acceptance - without consuming more resource or costing more than needed.

 

Through comprehensive scientific ‘pressure testing’, we’ll help you get your non-clinical safety assessment program right from the start–keeping to the development timelines and increasing the chance of the program’s acceptance by the regulatory authorities. These programs are typically presented during interactions with regulatory authorities to seek agreement and avoid unnecessary studies.

 

Keeping novel developments within safe parameters

 

Our non-clinical safety assessment program development solution is designed for developers of biopharmaceuticals. It is usually implemented prior to first in-human studies, but provides valuable support along the subsequent clinical development process too.

Our experts have extensive experience in developing non-clinical safety assessment programs with almost all biopharmaceutical product classes. We specialize in developing highly product-specific safety assessment programs for novel and previously clinically untested products, such as advanced therapies (ATMPs)/cell and gene therapy products.

 

Get In Touch

Insights Hub

Sharing 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.
29.11.21
Biopharma Excellence

Roadmap to commercialization success: Build agility into drug development plans

By Dr. Diane Seimetz

We know the lifechanging impact that gene, cell and tissue-based therapies..

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.

Socials: