BioAgile Therapeutics runs clinical and consumer research across eight regulated categories in India. Each sector answers to a different authority and a different evidence standard, so the study design, the endpoints and the documentation change with it.
Whether you need a Schedule Y clinical trial, an FSSAI-defensible nutraceutical claim, dermatological tolerance testing or a clinical evaluation for software as a medical device, the work below is run from our Bengaluru operation under ICH-GCP and an ISO 9001:2015 certified quality management system.
Pharmaceuticals
BioAgile Therapeutics supports pharmaceutical sponsors across the full development path — Phase I to Phase IV trials, bioavailability and bioequivalence studies, regulatory dossiers and post-marketing safety. Studies are conducted under the New Drugs and Clinical Trials Rules 2019 with ethics committee oversight and CDSCO submission support.
Nutraceuticals
BioAgile Therapeutics generates human efficacy and safety evidence for nutraceutical, dietary supplement and functional food brands. Studies are designed so the resulting data can substantiate label and marketing claims under FSSAI expectations rather than sitting unused in a report.
Cosmeceuticals
BioAgile Therapeutics runs dermatological efficacy, skin and eye tolerance and instrumental assessment studies for cosmeceutical and personal care brands. Endpoints are chosen to withstand scrutiny of the specific cosmetic claim being made, from hydration and pigmentation to sensitivity and patch testing.
SaMD (Software as a Medical Device)
BioAgile Therapeutics designs clinical evaluations for software as a medical device, covering algorithm performance, usability validation and real-world clinical data collection. Studies are structured for the CDSCO Medical Device Rules 2017 classification pathway, with participant data handled under the DPDP Act 2023.
Fast-Moving Consumer Goods (FMCG)
BioAgile Therapeutics conducts consumer and clinical studies for FMCG brands, generating human evidence for product performance, sensory response and advertising claims. Protocols combine controlled clinical measurement with consumer perception data so a claim is defensible commercially and scientifically.
Biotechnology
BioAgile Therapeutics supports biotechnology sponsors developing biologics, biosimilars, vaccines and advanced therapies, from preclinical packages through to Phase IV. Comparative and immunogenicity study designs are built to the evidence expectations that apply to biosimilar and novel biologic submissions in India.
Ayurvedic & Herbals
BioAgile Therapeutics conducts safety, efficacy and label claim studies for Ayurvedic, herbal and traditional medicine products. Protocols reconcile classical formulation practice with the controlled measurement and documentation that AYUSH requirements and modern evidence review expect.
Veterinary
BioAgile Therapeutics runs veterinary clinical research covering animal health product safety, efficacy studies and multi-site field trials. Studies are conducted with institutional animal ethics committee oversight and documented to support product registration and label claims.
Not sure which pathway applies?
Regulatory classification decides almost everything downstream — the authority, the study design, the endpoints and the documentation set. If your product sits between categories, or you are not certain whether it needs a clinical trial or a claim substantiation study, send us the product profile and our regulatory team will map the route.
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