Zetalix is a full-service Clinical Research Organization (CRO) headquartered in India, delivering end-to-end clinical trial management, regulatory strategy, and market access solutions for pharmaceutical, biotech, and nutraceutical companies worldwide.
Phase I–IV clinical trial design, execution, and monitoring across 15+ therapeutic areas. GCP-compliant protocols with global regulatory alignment.
End-to-end regulatory submission support — IND/NDA filings, CDSCO dossier preparation, and international regulatory harmonization through ICH and CTD frameworks.
Design and execution of bioavailability and bioequivalence studies for generic drug approvals, conducted at NABL-accredited laboratories and WHO-prequalified sites.
roactive safety surveillance, adverse event reporting, PSUR/PBRER preparation, and risk management planning in compliance with Indian and international mandates.
CDISC-compliant data capture (SDTM/ADaM), statistical analysis plans, interim analyses, and CSR-ready datasets using validated EDC platforms.
Regulatory-grade documentation — clinical study protocols, investigator brochures, CSRs, CTD Module 2 summaries, and peer-reviewed manuscript support.
Access to 500+ pre-qualified clinical trial sites across India with curated investigator networks, site feasibility assessment, GCP training, and real-time performance dashboards.
Key Statistics:
India has rapidly transformed into one of the world's most strategic destinations for clinical research. A vast treatment-naïve patient population, competitive operational costs, a robust regulatory modernization trajectory under CDSCO and the New Drugs & Clinical Trials Rules (2019), and a deep bench of medically trained investigators make India the market of choice for sponsors seeking speed, scale, and scientific quality.
Zetalix is positioned at the intersection of India's clinical trial ecosystem and global standards — ensuring every study meets ICH-GCP benchmarks while leveraging India's unique advantages in recruitment velocity, therapeutic diversity, and cost efficiency.


Every clinical program is unique. Zetalix builds a customized regulatory and operational roadmap for each sponsor — reducing timelines, mitigating risk, and ensuring compliance from Day 1 to market authorization.
Zetalix supports pharmaceutical companies across the entire product lifecycle — from pre-IND strategy through Phase IV post-marketing surveillance. Our expertise spans innovator drugs, generic programs, and combination products.
Key Services:
India's nutraceutical market demands nuanced understanding of FSSAI regulations, health claim substantiation, and the CDSCO–FSSAI interface. Zetalix guides international companies through every step of Indian market entry.
Key Services:
Biologics and biosimilars follow distinct regulatory requirements in India. Zetalix provides specialized expertise in biosimilar development, immunogenicity assessment, and comparability studies.
Key Services:
India's medical device regulations are evolving under CDSCO's Medical Devices Rules (2017). Zetalix supports device companies with clinical investigation planning, regulatory classification, and market authorization.
Key Services:
Zetalix
Northstar, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka 560064, India
Copyright © 2026 Zetalix - All Rights Reserved.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.