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.
Leading Clinical Research Since 1997
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400
Clinical Trials in 40+ Indications
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150+
Publications
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4000+
Regulatory Projects Completed
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27
Years In Business
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45,000
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.
As part of our multi-million-dollar research program, KGK has played an important role in helping us confirm the health benefits of our products, especially VitaFiber IMO. Their clinical trial research has contributed to our submission and product acceptance by the world’s top health regulatory agencies. They are a thoroughly professional organization with a strong understanding of businesses’ requirements.
We are so grateful to have been introduced to the professional team at KGK Science. They were patient with our inexperience, assisted us in building a reputable program, created education opportunities with top-notch experts in the field of Dietary Supplements and FDA regulations and guided our models to create truly imaginative studies that will contribute to the scientific body of knowledge in an honorable way.
KGK is responsive and adaptive to our needs, which is important to get a human clinical trial done with good design and within the time frame.
