Helping pharma, biotech and device clients navigate complex global requirements and emerging issues

  • 30+

    Years' experience
  • 100+

    Regulatory experts
  • 60+

    Projects in over 60 countries

When millions are at stake, navigating complex global requirements, trends, and emerging issues is critical. We work with you to take a rigorous, integrated, strategic approach to global regulatory affairs. Our global team has worked with hundreds of clients in more than 60 countries.

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

Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research, investment, and legal firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

Comprehensive services for the complete product life cycle

  • Pharmacovigilance
  • Quality Services
  • Regulatory Maintenance of Approved Products
  • Medical Information Services
  • Medical Device Regulatory Services
  • eCTD Services
  • Environmental Regulatory Services
  • Compliance Services
  • CMC Services

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

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

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.