A smoother path to regulatory success
Our Global Regulatory Affairs (GRA) support service is designed to guide you through every stage of your discovery and development journey - helping you to reduce risks, accelerate timelines, and increase your chance of success at every step.
From discovery and early-stage development to large-scale manufacturing and clinical trials, our innovative strategies and integrated solutions are designed to empower biotechnology and pharmaceutical companies - all the way from concept to cure.
Bringing new drugs to market has always been a challenge. With new modalities such as biologics or cell and gene therapies on the rise, the regulatory pathways become even more challenging because they often still need to be designed and discussed early in development with the regulatory bodies.
We at Evotec understand what it takes to bring a new drug to market from both a scientific and a regulatory perspective because we have everything you need for discovery, development, and regulatory success under one roof.
We can help you developing a smooth and straightforward strategy for your product by guiding you through the IND submission process, including any meetings with regulatory authorities or consultation as we recommend them when providing you with the strategic view.
Our global regulatory affairs team manages your projects, whether integrated or stand-alone, as carefully and with the same dedication as our internal proprietary R&D projects. We treat your project as if it was our own.
Together with your experts, we prepare the best applicable strategy and we take care of your regulatory submissions; we are at your side when it comes to preparing and facilitating the necessary meetings with regulators. All in an agile, flexible, and adaptable manner.
All modalities welcome
We offer support, insight, and expert guidance for a full range of modalities, from small molecules and mAbs to oligonucleotides and even the newest advanced modalities such as cell and gene therapy. We can support you in defining the orphan status of your product and opening an accelerated and incentivized development and approval for high unmet medical need products.
Evotec’s Global Regulatory service team can support you throughout your entire discovery and development journey; ensuring sound regulatory strategy is built into your R&D program from day one.
We provide you with tailored regulatory strategic input and support from detailed needs analysis and the definition of the target product profile, right through to support with health authority meetings, and complex regulatory submissions.