Skip to content

Regulatory Submissions

Stake Your Claim

As a full-service CRO, KGK Science has an entire team of regulatory professionals to handle all the necessary regulatory submissions for clinical trials and product approvals. Ensuring a seamless end-to-end process, we will work directly with your team to develop the required materials, submit to Health Canada, FDA, EFSA and other regulatory boards on your behalf, and handle all correspondence until approvals are received.

Our team of regulatory experts, led by a former federal regulator with the FDA, is available to provide consulting throughout the clinical trial process. With a full offering of regulatory services, KGK can also be contracted to submit to a regulatory board on your behalf for a clinical trial being run at an outside site or to obtain product approvals.

  • Expert regulatory team led by a former FDA regulator
  • Full regulatory submission development and correspondence
  • Regulatory contract and consulting services

Regulatory Consulting Expertise

Led by a former FDA Regulator, KGK’s seasoned regulatory experts are uniquely equipped to provide an insider’s perspective into regulatory operations and the most effective way to navigate a timely and compliant path-to-market. Backed by a vast network of scientific, legal, and regulatory professionals, you’ll receive dedicated support throughout each step of the process. 

Expert Regulatory Services

Leading Clinical Research Since 1997

  • 350

    Clinical Trials Across 40+ Indications

  • 150

    Publications

  • 10M

    Data Points Collected

  • 23

    Years In Business

  • 85

    Full Time Employees

  • 25,000

    Participant Database

Supporting Your Business with High-Quality Expertise

As a premium full-service contract research organization, KGK Science provides clinical trial research and regulatory services that meet the highest quality standards, customized to meet the needs of our clients. Contact us today and stake your claim.

Request a 3-Day Quote

Interested in learning more about how KGK Science can help move your product to market with confidence? Simply fill in the form below and someone will be in touch with you within 24 business hours.
  • Area of Interest * Required
  • Consent