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History

Brick by Brick, Zenovel carefully crafted for Excellence

Founded in 2020 under the dynamic and visionary leadership of Mr.RakeshSutariya, Zenovel has embarked on a remarkable journey to simplify regulatory complexities while upholding the highest standards of ethical integrity.

In just four years, we have established ourselves as a trusted partner in the healthcare and pharmaceutical sectors, setting new benchmarks of excellence through innovation and unwavering commitment. Our team, a powerhouse of expertise, combines over a decade of collective experience. This unique blend of industry veterans and forward-thinking professionals enables us to anticipate and adapt to emerging trends, helping our clients maintain a competitive edge.

Zenovel’s dedication to excellence and client success has fuelled our expansion across multiple nations, strengthening our global footprint. Our GMP support services, lauded by clients worldwide, exemplify our unwavering commitment to quality and reliability.

With an impressive track record of 332 successful audits for prominent companies, we have consistently nurtured partnerships, built trust, and catalysed transformative growth for our clients. This dedication earned us the prestigious recognition as one ofIndia Pharma Outlook’s Top 10 Pharmaceutical Regulatory Consultants for 2024. This accolade underscores our leadership in the field and reinforces our position as the preferred partner for pharmaceutical and healthcare organizations globally.

At Zenovel, we take pride in our customer-centric approach. We have supported over 50 international clients in achieving their healthcare goals, offering tailored solutions to navigate regulatory landscapes, ensure compliance, and drive innovation.

As we expand our horizons, Zenovel remains steadfast in its commitment to fostering partnerships built on integrity, transparency, and quality. Together, we are shaping the future of pharmaceuticals and healthcare—one milestone at a time.

  • Zenovel Roadmap for upcoming 10 years

After reaching significant milestones in our journey so far, Zenovel looks forward to an even brighter and more impactful future. Our strategy is rooted in the belief that success is achieved in stages, with each action taken today laying the foundation for future accomplishments.

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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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  • 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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