CATO SMS experts deliver specialized product development services and solutions, designing and executing studies in complex indications and modalities. Our extensive regulatory affairs experience in clinical research enables us to deliver innovative strategies and consulting insights as you navigate the approval process.

With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trials in more than 25 countries.

  • You can count on our expertise to guide your team through complex regulatory requirements; we deliver over 750 regulatory submissions a year. Over 30 years of global experience ensures effective and efficient IND and CTA filings as well as meetings with the FDA, EMA, and country-specific governing authorities.
  • With in-depth expertise and hands-on experience, we meet your challenges, anticipate obstacles, and seize opportunities that arise before or during clinical trial study conduct.

CATO SMS has the knowledgeable experts to tackle your toughest challenges with confidence and precision in areas including:

Clinical Trial Operations

Regulatory Consulting

Medical Affairs & Pharmacovigilance

Strategy & Consulting

Data Management & Biostats


We provide valuable insight, high-quality deliverables, and unmatched client service, giving emerging and midsize biopharmaceutical companies like you expert guidance to identify the specialized solutions you need, every step of the way. We know how important your product is to you and the patients who are waiting.