Preparing a regulatory submission for global regulatory approval requires significant expertise, effort, and attention to detail. A large, diverse team, numerous tools, planning, and processes must work together in harmony for a successful outcome. Complexity, risk, time, and costs typify every submission. Without careful execution and the ability to navigate unexpected challenges, your submission may face costly delays.
Certara Regulatory Science, also known as Synchrogenix, assures and accelerates the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Our proven record of success is built on our expertise, and an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.
Here is what our partners say:
“I consider Synchrogenix to be the gold standard for our vendors because of the excellent service they provide.” – Vice President, Regulatory Affairs | Banner Life Sciences
“You may have seen the announcement that the FDA has accepted our NDA filing. I just want to say, thank you to each and everyone else at Synchrogenix and Certara who helped us get to this point. There’s more to come, but this is a big deal for us and soon for patients. We couldn’t have done it without you.” – Vice President, Program Management at a biopharmaceutical company
How we help our clients
We focus on regulatory strategy first, and then map an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management.
We ask the right questions during front end meetings and working together, assess the right processes, tools, and resources to achieve all your goals.
An astonishing number of documents, communications, and presentations must be produced at every stage of development.
Our highly skilled and scalable team manages the transition from pre-clinical programs to clinical development, through submission and approval, to post marketing safety with rigorous and proven quality control processes.