BioAgile Therapeutics Pvt Ltd is an ISO 9001:2015 certified, CDSCO-approved Clinical Research Organisation headquartered in Bangalore, India. We design and run clinical studies across regulated consumer-health and life-science categories, applying ICH-GCP principles, Schedule Y and the New Drugs and Clinical Trials Rules 2019 to every protocol we deliver.
Each category below follows a different Indian regulatory pathway, so the study design, endpoint selection, ethics-committee route and documentation package differ accordingly. Use the sections below to find the industry closest to your product, or contact us if your product sits across more than one category.
Pharmaceuticals
BioAgile Therapeutics conducts clinical research for pharmaceutical sponsors developing new drugs, generics and fixed-dose combinations for the Indian market. Studies are designed under Schedule Y and the New Drugs and Clinical Trials Rules 2019, with CDSCO submissions, ethics-committee coordination, site selection from our investigator network and monitoring handled end to end. Our teams support Phase I to Phase IV programmes, bioequivalence work and post-marketing surveillance, with data management and biostatistics aligned to ICH-GCP.
Clinical research services for pharmaceuticals →
Nutraceuticals
BioAgile Therapeutics runs human efficacy and safety studies for nutraceutical, dietary supplement and functional food companies. In India these products fall under FSSAI regulation, which sets out permitted ingredients, claim substantiation expectations and labelling requirements. We build protocols that generate defensible evidence for the specific claim a sponsor intends to make — bioavailability, tolerability, or a measured physiological endpoint — with ethics-committee approval, volunteer recruitment from our panel and independent statistical analysis.
Clinical research services for nutraceuticals →
Cosmeceuticals
BioAgile Therapeutics supports cosmeceutical and personal-care brands with dermatological and instrumental testing on human volunteers. Typical programmes cover patch testing, skin-irritation and sensitisation assessment, dermatologist-supervised safety-in-use studies, and instrumental efficacy measurement for hydration, elasticity, pigmentation and photoprotection. Studies run under BIS test methods and ethics-committee oversight, producing claim-support documentation suitable for Indian regulatory and consumer-facing use.
Clinical research services for cosmeceuticals →
SaMD (Software as a Medical Device)
BioAgile Therapeutics designs clinical investigations for digital health products classified as Software as a Medical Device. In India, SaMD is regulated under the CDSCO Medical Device Rules 2017, which set out risk classification, clinical evidence expectations and the notified-body route. We support clinical performance evaluation, usability and human-factors assessment, and real-world evidence collection, with data handling built to comply with the DPDP Act 2023.
Clinical research services for SaMD →
Fast-Moving Consumer Goods (FMCG)
BioAgile Therapeutics conducts consumer-safety and claim-substantiation studies for FMCG manufacturers across oral care, home care, hygiene and personal-care ranges. Work is grounded in BIS standards and consumer-safety testing methodology, combining controlled clinical assessment with in-use consumer studies. We handle protocol design, ethics-committee approval, recruitment of representative volunteer cohorts, blinded assessment and statistical reporting so that advertised claims rest on documented human data.
Clinical research services for FMCG →
Biotechnology
BioAgile Therapeutics partners with biotechnology companies developing biologics, biosimilars, vaccines and cell-based products. These programmes follow Schedule Y and the New Drugs and Clinical Trials Rules 2019, with CDSCO review and, where applicable, additional institutional biosafety approvals. We support first-in-human and comparative clinical studies, immunogenicity and pharmacokinetic sampling logistics, cold-chain-sensitive site management, and biostatistical analysis for comparability assessments.
Clinical research services for biotechnology →
Ayurvedic & Herbals
BioAgile Therapeutics designs and runs clinical studies for Ayurvedic, Siddha, Unani and herbal formulations under the AYUSH regulatory framework. Requirements differ from conventional pharmaceutical pathways: classical formulations, patent and proprietary medicines and extract-based products each carry their own evidence expectations. We work with the sponsor to define appropriate endpoints, secure ethics-committee approval, recruit suitable participants and produce a documented safety and efficacy dataset.
Clinical research services for Ayurvedic and herbal products →
Veterinary
BioAgile Therapeutics carries out clinical studies for veterinary pharmaceutical, feed-additive and animal-health products. Programmes cover target-animal safety, field efficacy across companion and production species, palatability assessment and residue-related study support. Protocols are written with animal-ethics-committee oversight and species-appropriate endpoints, and we coordinate the veterinary investigator sites, sample logistics and statistical reporting required to assemble a submission-ready evidence package.
Clinical research services for veterinary products →
Not sure which pathway applies?
Products often sit across more than one category — a botanical ingredient positioned as a supplement, or a device paired with companion software. If you are unsure whether your product follows the CDSCO, FSSAI, AYUSH or BIS route, send us the product details and intended claim and our regulatory team will map the applicable pathway before any protocol work begins. Send an enquiry, or read our frequently asked questions for background on how our studies are structured.
