With over 25 years of experience in medical research and writing, Thera-Business is positioned as a preferred partner across the pharmaceutical, medical device, and government sectors. The company’s services include: FDA submissions (i.e., 510Ks; INDs, PMAs, NDSs, SEs, CSRs, PSURs, and IBs); systematic reviews/ meta-analyses; RWE/HEOR/clinical study design and execution; survey design, post-market surveillance; study protocols (i.e., synopses and amendments); and EU MDR/IVDR implementation.

Thera-Business is distinguished by its world-class team of experts with unparalleled clinical, technical, and writing skills. Ranging from the simplest to highly complex, we have an extensive track record of successfully completing projects accurately, efficiently, on-time, and according to predefined budgets.

Our broad range of services build from a foundational collaboration with each client that responds to their specific needs and ensures the successful execution of projects. Our demonstrated history of excellence empowers clients to adeptly and successfully navigate the intricate challenges of the regulatory landscape.