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Zenovel Experience

Designing Future Roads with Proven Expertise and Experience

Our Expertise illuminated our Client’s Past, empowered their Present, and will elevate their Future

Over the years of varied experience and successfully completed numerous projects and clinical trials, Zenovel has flourished through reliable, high-quality services grounded in industry expertise.

We built on Decades of Experience and Excellence

GCP
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GMP
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Patient based BE trial
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Zenovel is a global leader in providing comprehensive GCP services, ensuring compliance, data integrity, and quality in clinical trials and research activities. Our experienced team comprises 25+ full-time experts and 450+ contractual auditors/monitors worldwide.

Extensive team experience Across Patient- Based BE Trials

Substantial Preclinical and Clinical Services Expertise

Zenovel’s team is proficient in managing preclinical and clinical research services, ensuring GCP and GLP compliance.

  • Preclinical Monitoring and Audits: 25+ studies, 12+ training sessions.
  • Clinical and Analytical (BA/BE, Phase I-IV)
  1. 1000+ monitoring activities for BA/BE studies
  2. 100+ late-phase trials (Phase II-IV)

  • Undoubtedly the best GMP Service Competence

Zenovel’s GMP services showcase our industry-leading expertise and deep-rooted experience. Our team’s collective proficiency spans a variety of facility audits and support activities, including

Our extensive experience with over 150 global clients, including top generic pharmaceutical firms, demonstrates our commitment to providing exceptional supply chain support and GMP compliance.

  • Affordable, Innovative and Holistic Regulatory Approach

The regulatory team at Zenovel has extensive experience in compiling, reviewing, and submitting dossiers, with key points to emphasize

Blogs and news

Our Latest Article

Nitrosamine Control

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

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Nitrosamine Control

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

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Risk-Based Monitoring

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

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Mastering Inhalation Studies

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

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Data integrity

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

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GCP Audit and Monitoring

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

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We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
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Contact Us

  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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