Zetalix
Zetalix
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  • About Us
  • Core Services
    • Clinical Trial Management
    • Regulatory Affairs
    • Bioequivalence & BA/BE
    • Pharmacovigilance
    • Data Management
    • Medical Writing
    • Site Management
  • Regulatory Landscape
    • Managing Regulation
    • Regulatory Assessment
  • Why India
  • Contact Us

Accelerating Clinical Breakthroughs. From Concept to Market

Accelerating Clinical Breakthroughs. From Concept to MarketAccelerating Clinical Breakthroughs. From Concept to MarketAccelerating Clinical Breakthroughs. From Concept to Market
Get Started Today

Accelerating Clinical Breakthroughs. From Concept to Market

Accelerating Clinical Breakthroughs. From Concept to MarketAccelerating Clinical Breakthroughs. From Concept to MarketAccelerating Clinical Breakthroughs. From Concept to Market
Get Started Today

Welcome to Zetalix Solutions

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.

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Comprehensive Clinical Research Services

Clinical Trial Management

Bioequivalence & BA/BE Studies

Regulatory Affairs & Strategy

Phase I–IV clinical trial design, execution, and monitoring across 15+ therapeutic areas. GCP-compliant protocols with global regulatory alignment.

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Regulatory Affairs & Strategy

Bioequivalence & BA/BE Studies

Regulatory Affairs & Strategy

End-to-end regulatory submission support — IND/NDA filings, CDSCO dossier preparation, and international regulatory harmonization through ICH and CTD frameworks.

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Bioequivalence & BA/BE Studies

Bioequivalence & BA/BE Studies

Pharmacovigilance & Drug Safety

Design and execution of bioavailability and bioequivalence studies for generic drug approvals, conducted at NABL-accredited laboratories and WHO-prequalified sites.

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Pharmacovigilance & Drug Safety

Pharmacovigilance & Drug Safety

Pharmacovigilance & Drug Safety

roactive safety surveillance, adverse event reporting, PSUR/PBRER preparation, and risk management planning in compliance with Indian and international mandates.

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Data Management & Biostatistics

Pharmacovigilance & Drug Safety

Data Management & Biostatistics

CDISC-compliant data capture (SDTM/ADaM), statistical analysis plans, interim analyses, and CSR-ready datasets using validated EDC platforms.

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Medical Writing & Publications

Pharmacovigilance & Drug Safety

Data Management & Biostatistics

Regulatory-grade documentation — clinical study protocols, investigator brochures, CSRs, CTD Module 2 summaries, and peer-reviewed manuscript support.

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Site Management & Investigator Networks

Site Management & Investigator Networks

Site Management & Investigator Networks

Access to 500+ pre-qualified clinical trial sites across India with curated investigator networks, site feasibility assessment, GCP training, and real-time performance dashboards.

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Why India

India — The World's Emerging Clinical Trials Powerhouse

Key Statistics:

  • 1.4 Billion+ — Diverse patient population across all demographics
  • 40–60% Lower — Clinical trial operational costs vs. US/EU
  • 3,500+ — GCP-compliant clinical trial sites nationwide
  • 700+ — DCGI-approved trials annually
  • #3 Globally — In pharmaceutical production capacity


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.

Discover Why India

Clinical Trial Workflow

Our Proven Clinical Trial Workflow — Product Evaluation to Market Launch

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.

Regulatory Services

Industries We Serve

Specialized CRO Expertise Across Life Sciences

Pharmaceuticals

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:

  • Phase I–IV clinical trial management
  • BA/BE studies for generic approvals
  • CDSCO new drug applications (NDAs)
  • 505(b)(2) / hybrid application strategy
  • Post-marketing surveillance and PSUR management


Nutraceuticals & Health Supplements

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:

  • FSSAI product classification and licensing
  • Health claim clinical substantiation studies
  • Stability studies (ICH Zone IV conditions)
  • Labeling and advertising compliance
  • Import registration and distribution strategy


Biotechnology & Biologics

Biologics and biosimilars follow distinct regulatory requirements in India. Zetalix provides specialized expertise in biosimilar development, immunogenicity assessment, and comparability studies.

Key Services:

  • Biosimilar clinical development programs
  • Immunogenicity study design and analysis
  • Comparability and biosimilarity assessment
  • CDSCO biologics pathway navigation
  • Cell and gene therapy regulatory guidance


Medical Devices

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:

  • Device classification under Indian MDR
  • Clinical investigation design and execution
  • Performance evaluation reports
  • CDSCO device registration and import licensing
  • Post-market clinical follow-up (PMCF)

Get Started Today

Zetalix

Northstar, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka 560064, India

(+91) 89718 32402 info@zetalix.com

Copyright © 2026 Zetalix - All Rights Reserved.

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