Helping clients to navigate complex global regulatory requirements and emerging issues

  • 30+

    Years' experience
  • 100+

    Regulatory experts
  • 60+

    Projects in over 60 countries

We work with you to take a rigorous, integrated, strategic approach to global regulatory affairs. Our global regulatory consulting and advisory team has worked with hundreds of clients in more than 60 countries.

For any project, at any phase, anywhere in the world

Our strategic regulatory consulting experts serve clients around the globe—from biotech start-ups to global pharma and medical device—as well as the research, investment, and legal firms that serve them.Our comprehensive regulatory consulting services include:

Strategy

Strategy

Having the right strategy is crucial at all stages of the product lifecycle. Whether you’re preparing for your first pre-IND/CTA meeting or approaching patent expiration, we will help you consider all the options so you can take the most strategic stance.

Submissions

Submissions

Doing a submission right the first time can make the difference between being first to market or just another me-too. Whether it’s an eCTD to the FDA, an orphan drug application in Europe, or a medical device in Canada, our experts will help you get to market quickly and smoothly.

Support

Support

We provide temporary on-site support for organisations that find themselves suddenly overloaded. Our extra hands and minds can make things happen fast—and by providing you with regulatory assistance on routine work, our support can help you focus on your top priorities.

To learn more or to speak with an expert, contact us today.