OneSource Regulatory

One Source Regulatory is the leader in creating value and efficiencies for healthcare clients by designing and implementing Regulatory and Healthcare Compliance Solutions, and Medical review outsourcing. Our firm is staffed by ROCK STARS of the industry (yes, we said rock stars) who have done the job in companies of all sizes – from large multi-nationals to start-up organizations.

Our rock stars are value creators. We bring knowledge and experience to your company for as long as you need it.

o Need a rock star regulatory person to help with your study design for optimal marketing claims, label development, or guidance navigating FDA submission/review? Our rock stars have deep experience working with the FDA. We help maximize your label and marketing claims based on your data. In other words, increased shareholder value!

o Want to make your Promotional Review Committees ROCK? Our rock stars are all seasoned experts at effective regulatory and medical review. We partner w