The Approach
The foundation of Regulatory Affairs is to stay current with emerging global standards for advanced therapies. From that foundation, we leverage our experience to apply a Quality-by-Design mentality to our work. This risk-based approach will ensure that our development of both analytical and manufacturing processes will consistently fall within a properly validated design space, thereby ensuring your product has a clear regulatory path with CMC life cycle management in mind.
Global Regulatory Standards
We stay up to date on all current global regulatory standards, so you don’t have to
Define Regulatory Pathway
We perform GAP assessments to ensure you have a fully formed regulatory strategy from concept to commercialization
QBD and Risk-based Approach
From study design support, to advising on phase-appropriate GMP’s, we ensure your product follows a risk-based approach
Life Cycle Management
Our risk-based approach and CMC product lifecycle expertise improves regulatory predictability while saving you time
Regulatory Affairs
We offer strategic guidance to our clients and offer cell and gene therapy IND filing support. To maximize clinical trial manufacturing success rates, we dive deep into the details of study design to ensure we are developing methods and processes with operating parameters that fall within an ideal, validated design space. From the big picture down to the execution details, our Regulatory Affairs team can help improve the regulatory predictability of your product.