Nutraceuticals / Novel Foods / Food Additives / Color additives / Prebiotics / Probiotics / Food Contact Substances

Adgyl Lifesciences has the expertise to design the most cost-effective testing strategy for regulatory approval on herbals, nutraceuticals, food ingredients, color additives, or preparations which are combinations of Botanical ingredients as per FDA Red Book/ CFSCAN/EFSA requirements. Adgyl Lifesciences is registered on the Connect EFSA database and can be notified as a laboratory in charge of potential studies. The following is a typical strategy that can be customized project specific and based on available information with the Sponsor or in the public domain.

Strategy for Regulatory Approval

• History of human use.
• GRAS status and dosing of purified substance vis-à-vis the herbal ingredient.
• Possibility of abbreviated testing by designing a testing strategy that will be acceptable to the agency of choice.
• Design of exploratory toxicity and kinetics (wherever possible) studies to address key points of the testing strategy and establish a case for safety testing by abbreviated strategy.
• CMC information to demonstrate quality control measures of a combination drug product.
• Preparation of the package for the pre-IND meeting with the agency of choice.
• Support during the pre-IND/ regulatory meetings as required.
• Conduct CMC, Genetox and Repeated Dose Toxicology studies.

The following studies are offered: