We are GLOBAL Regulatory Writing & Consulting, an exciting company with grit, stamina, and the determination to be the best partners in the biotechnology industry. Our medical device and IVD services include Regulatory Consulting, Writing Solutions, Project Management, Regulatory Technology, and Training & Education. From initial submission through post-market clinical follow-up, we bring a wealth of MDD, MDR, and IVDR expertise to your projects. For those marketing in the US, we support 510(k) and PMA pathways, IDE-level clinical studies, and all aspects of post-market surveillance.

Our carefully assembled dream team of clinical, regulatory, engineering, quality, and writing professionals boasts over 75 years of combined medical device, clinical, and IVD experience. We work continuously to become leaders in the medical device space, developing a hard-earned reputation by tackling the toughest projects on-budget, and in record time. Whether it's being the go-to resource for large companies, supporting entire portfolios for mid-size companies, or providing training and consulting services for small companies, Global is positioned to support any need. To date, we have worked on regulatory strategy and submissions for over 1,500 medical devices, including class I-III devices, active implantable medical devices (AIMD), and software as a medical device (SaMD).