Safety Assessment

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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.


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If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.


    We are now Cencora PharmaLex 

    PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

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