Nutraceuticals, Functional Food and Dietary Supplements
Clearing the scientific and regulatory path
The commercial potential of Nutraceuticals, Functional Foods and Dietary Supplements has grown to very substantial proportions. However, the increasing complexity of the regulatory requirements to warrant safety and to support product claims for nutraceuticals, functional foods and dietary supplements, may represent a pathway full of hurdles.
Kinesis Pharma can help you to navigate through the scientific and regulatory requirements these products encounter during the development process before they are granted market authorization.
Kinesis can support your product manufacturing and control and evaluates the nonclinical and clinical safety of your product. It also identifies and substantiates possible health claims, and designs, subcontracts and monitors safety and efficacy studies for you. In addition, Kinesis offers advice on regulatory procedures and development strategies, and prepares concomitant reports, summary documents and dossiers. Kinesis is therefore able to respond to a wide variety of your food-and nutraceutical related needs, whether you are a start-up-company or a big established company.
Consultancy
Kinesis has a high level of experience and expertise in the field of nutrition. Kinesis advises you on health claims opportunities and strategic development options for functional food or nutraceuticals. Kinesis can also support you to identify the nonclinical and clinical safety profile of your product to meet the regulatory requirements. In addition, Kinesis prepares literature overviews and recommendations in a wide range of health areas.
Product chemistry, manufacturing and control (CMC)
Kinesis develops strategies for product chemistry and manufacturing, gives you valuable technical input and supports you with the various aspects of the production process of your product. Furthermore, Kinesis can help you by reviewing and analyzing manufacturing processes and product specifications for compliance with regulatory requirements and standards for nutraceuticals and functional food.
Non-Clinical and Clinical services
In order to demonstrate the safety and/or efficacy of your functional food or nutraceutical and to substantiate claims in accordance with regulatory guidelines (EFSA/FDA), Kinesis helps you to design, develop and outsource all the necessary nonclinical and clinical safety and efficacy studies.
Kinesis has an extensive network of CRO’s and work closely with them and its clients to design, coordinate and monitor these studies. If needed, Kinesis can qualify and audit CROs on your behalf to ensure protocol consistency and compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines.
Regulatory Affairs
Kinesis’ regulatory experts have up-to-date knowledge of the regulatory requirements in the field of nutrition, particularly novel food and nutraceuticals. Kinesis can support you with the development of a regulatory strategic plan. Furthermore, Kinesis prepares your regulatory dossiers (novel food dossiers, dossiers for health claim substantiation) and can represent you at the EFSA or the FDA.
"Let food be your medicine and medicine be your food (With thanks to Hippocrates)"
Contact details:Lucie van der Zee, Ph.D.,Director Project Management Nutraceuticals Tel: +31 76 54 80 667 Mob: +31 6 54 277 809 Email: Lucie.vanderZee@Kinesis-Pharma.com |
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