See how our regulatory solutions can help move your product forward.

Regulatory solutions and expertise with the FDA and global health authorities

To get your product to market quickly, your biopharma company needs regulatory consulting expertise you can trust. We’ve successfully worked with global health authorities and every review division of the FDA. Our regulatory solutions can reduce the risk of failure, and increase your speed to market.

  • 200+ industry-trained regulatory experts
  • 500+ product approvals supported worldwide
  • Product development experience in 25+ advanced therapies
  • 155+ NDAs/BLAs/ANDAs and 90+ investigational new drug applications (INDs) supported in the past 5 years

Tap into our various solutions, including:

  • Regulatory Affairs
  • Scientific/Medical Writing
  • FTE Models
  • Submission Operations
  • CMC (Chemistry, Manufacturing and Controls) 
  • Nonclinical
  • Compliance, Licensing, and Registration
  • Medical Device Consulting