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:
Genetic Toxicology Studies
  • Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
  • In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
  • In Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene (OECD 490)
  • In Vivo Mammalian Erythrocyte Micronucleus Test (OECD 474)
Toxicity studies
  • Acute Oral Toxicity study in Rodent
  • Maximum Tolerated Dose (MTD) toxicology studies in Mice/Rats
  • Maximum Tolerated Dose (MTD) toxicology studies in non-rodents (Beagle dog/Minipigs/NHP*)
  • Dose range finding (7 to 14 day) toxicology studies in Mice/Rats
  • Dose range finding (7 to 14 day) toxicology studies in non-rodents (Beagle dog)
  • 14 to 28 day repeat dose toxicity studies in Mice/Rats
  • 14 to 28 day repeat dose toxicity studies in non-rodents (Beagle dog)
  • 28-day neurotoxicity study in rodents
  • 90-day repeat dose toxicity studies in Mice/Rats
  • 90-day repeat dose toxicity studies in non-rodents (Beagle dog)
  • 90-day neurotoxicity study in rodents
  • Chronic Toxicity studies in Mice/Rats
  • One year (12 month) Chronic toxicity study in non-rodents (Beagle dog)
  • Carcinogenicity study in Mice/Rats
  • Combined Chronic Toxicity/Carcinogenicity study in Mice/Rats
  • Fertility and Early Embryonic Development (FEED) Study in Mice/Rats
  • One Generation Reproductive Toxicity Study in Mice/Rats
  • Two Generation Reproductive Toxicity Study in Mice/Rats
  • Prenatal Developmental Toxicity Study in Mice/rats/Rabbits
  • Neurotoxicity Study in Rats
  • Developmental Neurotoxicity Study in Rats
  • Pharmacokinetics study in Rats
  • Metabolism/Toxicokinetics/Mass balance study in Rats
  • Immunotoxicity studies

CASE STUDIES