Nutraceuticals
Integrated Compliance and Testing Services for Nutraceuticals
Industry focus
Safety and Toxicology Evaluation for Food Ingredients, Herbal Dietary Supplements and Nutraceuticals
Adgyl Lifesciences has the expertise to design the most cost-effective testing strategy for regulatory approval of herbals, nutraceuticals, food ingredients, color additives, or preparations that are combinations of botanical ingredients as per FDA Redbook/CFSCAN/EFSA requirements.
We are registered in EFSA for pre-submissions activities including being notified as a laboratory in charge for potential studies. Our regulatory approval strategy can be customiszed on a project specific basis, using available information provided by the customer or sourced from the public domain.
Core capabilities
- In vivo models for efficacy validation are:
- Metabolic syndrome, diabetes, obesity
- Inflammation & immune modulation
- Gut health & microbiome-linked models
- Cognitive & neuroprotective models
- Hepatoprotection & liver fibrosis models
- In vitro pharmacology
- Cell-based efficacy assays (anti inflammatory, antioxidant, metabolic)
- Enzyme inhibition assays (α glucosidase, lipase, COX, ACE)
- Receptor binding & signalling assays
- Gut microbiome & probiotic functional assays
- Cytotoxicity & genotoxicity screening
Regulatory Credentials
Regulatory & Quality Credentials
- First GLP-Accredited in India
We are the first GLP-accredited laboratory in India and has been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND/NDA packages.
- Certified Quality Standards
Our vivarium was the first to have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 2001 and all animal study protocols are reviewed and approved by the Institutional Animal Ethics Committee (IAEC), which is equivalent to Institutional Animal Care and Use Committee (IACUC).
Proven Experience
Established Expertise
With over 1100 clients and 30+ years of experience in conducting drug development studies. We are proud of our strong track record of regulatory submissions and robust historical control data and therefore feels confident in developing and thoroughly assessing the safety profile of your molecules. As an extension of your team, our scientists and technicians will help enable and expedite your research goals, ensuring that your preclinical drug development program provides quality data for key decision-making.
Clients
Years Experience
Global Regulatory Submissions
Investigational New Drug
(IND) packages submitted
- USFDA (US)
- EMA (Europe)
- MHRA (UK)
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- EMA (Europe)
- MHRA (UK)
- USFDA (US)
what people ask
Frequently Asked Questions
What services do you offer for nutraceuticals?
We provide integrated compliance, safety, and toxicology testing services.
Do you help design regulatory testing strategies?
Yes, we design cost-effective testing strategies for regulatory approval.
Which regulatory guidelines do you follow?
We align with FDA Redbook, CFSAN, and EFSA requirements.
Do you support EFSA-related submissions?
Yes, we are registered with EFSA for pre-submission activities and potential study support.
Can testing strategies be customised?
Yes, strategies are tailored based on project needs and available data from clients or public sources.
