Regulatory Submissions

KGK routinely submits to various regulatory boards for both clinical trials and product approvals. While submitting to a regulatory board is a part of our routine for our clinical trial clients, KGK also has the capability of being contracted to submit to a regulatory board on your behalf for a clinical trial you are running at an outside site or to obtain product approvals.

We can submit to Health Canada, the FDA and EFSA on your behalf. KGK will work with you to put together the entire submission. We have a checklist developed that easily lets our clients know the information we need for a seamless submission. Once the submission is complete, KGK will handle all correspondence with the regulatory board until the approvals are received.

KGK has the capability of submitting to other boards worldwide.

 

 

New Dietary Ingredient Notifications (NDINs)

NDI’s are dietary supplement ingredients that were not marketed in the US prior to the implementation

of DSHEA (October 15th 1994). They are required as a pre-market safety notification to the FDA at least 75 days prior to introducing the product to interstate commerce. An NDIN should demonstrate that an NDI is safe under the conditions of use. KGK Science will evaluate your NDI and assemble the notification document, facilitate any pre-clinical or clinical research that may be required to support the NDIN, and conduct a pre-submission meeting with the FDA on your behalf to present arguments for the scientific basis for the safety of your NDI. Finally, we will submit the NDIN and respond to any follow up queries that may arise. KGK Science has a proven track record of successful NDIN submissions.

 

Generally Recognized as Safe (GRAS) – Self-Affirmed or FDA Notices

GRAS status is required in order to prove that a food ingredient is exempt from the premarket approval requirements of Federal Food, Drug and Cosmetic Act. Proving a product is safe and generally recognized as such

is the responsibility of the company. Obtaining GRAS status requires both technical (scientific) evidence and proof that the safety of an ingredient for use in food is common knowledge. GRAS status can be self-affirmed by a company and/or a company can voluntarily submit a notice of GRAS status to the FDA. KGK Science will work with your company to evaluate the best regulatory approach to obtaining GRAS status. We will assess the information available on your product and provide you with a comprehensive plan that will meet the extensive requirements. Finally, we will conduct literature reviews; facilitate any pre-clinical or clinical research that may be required to support the GRAS status; publish the pivotal studies required to ensure that information on your product is generally recognized by the public; assess the safety of the product; prepare the GRAS dossier and facilitate a panel of experts to review the GRAS dossier; and prepare and submit GRAS notifications to the FDA.

 

Product License Applications – Health Canada

In order to market a dietary supplement (a.k.a. Natural Health Product) in Canada, premarket approval via a Product License must be obtained through the Non-Prescription and Natural Health Product Directorate (NNHPD) of Health Canada. Health Canada requires evidence of the safety and effectiveness of your product prior to issuing an Natural Product Number (NPN). KGK Science has extensive experience in working with the NNHPD and navigating the requirements for submitting a Product License Application (PLA). We will review the available information about your product and provide you with claims strategy that best fits your product. Lastly, we will conduct literature reviews, correspond with your manufacturers to gather required information, assemble and submit the PLA and respond to any additional queries that may arise.

 

Natural Health Product Master Files – Health Canada

Health Canada protects the proprietary information of companies by maintaining a Master File system in which companies may submit all of the required safety, manufacturing and efficacy information about their product that is required for use in Product License Applications and Clinical Trial Applications.

 

HC Master Files Timelines – Health Canada

Obtaining a Health Canada Masterfile allows companies to easily include their product in their customers products without giving away their trade secrets. KGK Science will review and assemble a Master File application, working with your quality department and conducting literature reviews to ensure that the package is as comprehensive as possible. KGK will then submit the Masterfile on your behalf and follow up as required.

 

Medical Devices

Based on classification, medical devices may have to be registered with the FDA or Health Canada prior to marketing. In the US, either a Premarket Approval (PMA) or 510(k) Premarket notification submission is required. In Canada, a Medical Device License (MDL) is required. For either country, data supporting the safety and efficacy of the device is assessed for compliance with standards through a regulatory submission. KGK Science will evaluate your device and predicate device (if applicable), determine the appropriate regulatory pathway, review the available data and if necessary, conduct the preclinical or clinical studies required to support your PMA, 510(k) or MDL submission. We will assemble your submission, conduct any required pre-submission correspondence with regulatory authorities and submit the application on your behalf.

 

Path to Market Consulting - Cannabis

Cannabis is a fast-moving industry with regulations that differ between jurisdictions and are constantly evolving. Navigating the regulatory pathways available can be difficult for any company bringing a cannabis product to market. Combining the required scientific expertise with regulatory expertise, KGK Science is able to aid any company in developing their product and a dossier of supporting data for regulatory submissions. We will work with you to understand your product and target market and develop an efficient regulatory path that reduces your regulatory risk. If necessary we will conduct any required pre-clinical or clinical studies and assemble any regulatory submissions required along the development pathway.

 

Market Research - Cannabis

Knowledge of the market and clients preferences is key to success in any industry. As the cannabis market matures and new products are developed, focus groups will be an important tool for innovative companies to utilize. KGK Science leverages it’s expansive participant database to locate the ideal candidates for facilitated focus group sessions. We will develop a custom designed protocol for the market research and provide a comprehensive analysis and interpretation of the data obtained. In order to do produce, process, sell for medical purposes or conduct research on cannabis in Canada, a Cannabis License is required. In order to obtain a license, an applicant must outline the activities that they will be conducting with cannabis and meet the appropriate requirements for processes, documentation, security and personnel. KGK Science can simplify this process for companies looking to work with cannabis. We will aid in this process by compiling and submitting the license application and corresponding with Health Canada throughout the process.

 

Label Review - Cannabis

Canada has strict labeling requirements for cannabis products that will evolve as regulations change. Understanding these requirements and how to any leverage opportunities available to make your product distinct will provide a competitive edge. KGK Science will review the product, market and planned label designs to ensure that you remain compliant while marketing your unique cannabis product.

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