Regulatory Affairs

Providing strategic regulatory guidance every step of the way.

Scientific expertise to develop, optimize, and implement your manufacturing process is a critical CDMO contribution. However, at Theragent we don’t overlook the positive impact that a sound regulatory strategy can have on our sponsors. This is why we offer our clients strategic regulatory guidance to help you de-risk your project – whether you are in early preclinical stages or moving towards commercialization of your cell or gene therapy.

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.