Regulatory Submissions

Quality regulatory submissions can accelerate your time to market.

Get Your Regulatory Submissions Right

Quality submissions are such an important part of the regulatory process; they have the ability to accelerate time to market and bring the benefit of these groundbreaking treatments to patients sooner.

Your success is dependent on the accurate crafting of the sections based on your design history files. At Suttons Creek, we pride ourselves on our ability to collaborate with Pharmaceutical companies and to get you across the regulatory finish line.

From regulatory submissions to standards analysis, from MAAs to RTQs, from essential design outputs to discussions with CDRH and CBER—we support and educate you from your initial contact with regulatory agencies through the final submission.

“Suttons Creek strikes the right balance between attention to detail and a systems-level approach.”

Bohdan Oppenheim, PhD, INCOSE