Advanced regulatory navigation skills

i3’s Regulatory Services group provides a broad spectrum of consulting support, from preclinical to commercialization and beyond. Under the leadership of a regulatory attorney, our regulatory affairs experts will work closely with you and regulatory agencies around the world to promote a compliant, high-quality, and efficient application process.

Regulatory services

On your behalf we can:

  • Interact with regulatory agencies to seek advice, agreement, and approval
  • Manage meetings with regulatory agencies
  • Ensure data generated in support of an application meets regulatory requirements
  • Prepare and submit applications that meet regulations and guidelines
  • Facilitate efficient review and approval
  • Advise on country-specific regulatory requirements
  • Provide issue-focused regulatory support
  • Provide regulatory due diligence evaluations of products or corporate acquisitions

Strategic consulting

We leverage our experience with drugs, biologics, and devices to provide a comprehensive product development strategy, drawing on the scientific rigor and excellence of our Medical and Scientific Services group. We also provide regulatory strategy, applying our expertise across multiple key regulatory authorities, countries, and therapeutic areas to the specific issues that affect each application.

Our consulting support does not end at the approval—we can also aid in developing commercialization and promotional plans.

Managing regulatory relationships globally

Working in partnership with sponsors, our project teams prepare and submit most investigation and marketing applications. We have experience with regulatory submissions in more than 50 countries, and maintain a central database of each country’s specific regulatory requirements.

i3 can facilitate a compliant, high-quality, and efficient application process.

Your objective is our objective

i3 regulatory affairs experts, supported by a spectrum of specialists, stand ready to support your team by facilitating and expediting your compliant, high-quality, and efficient application process on a global scale.