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Quality Management System Services

Ensuring your Success from Documentation to Compliance While Transforming for Sustainable Growth by our QMS Services

We strengthen your company performance by our effective QMS procedures & practices that meet customer requirements and regulatory adherence to ensure high quality product.

Zenovel enhances an organization’s performance by boosting customer confidence, increasing sales, and repeat business, and this ensures regulatory compliance and provides cost-efficient products and services, enabling expansion, growth, and profit. It also meets organizational requirements efficiently.

  • How do we assist in QMS?
  • Elements of Zenovel’s QMS

At Zenovel, our quality management system is a comprehensive approach that aims to meet the needs of an organization and its clients, encompassing various components that should be tailored to each organization’s specific requirements.

  • The company objectives and policies for quality
  • Quality manual
  • Data management
  • Internal process
  • Client satisfaction with product quality
  • Quality evaluation
  • Procedures, guidelines and recommendation
  • Why Choose Zenovel ?
  • Modification Control

We encourage continuous observation and modifications of processes, methods, materials, equipment, and documentation to enhance the safety and quality of finished goods.

  • Deviations

Our circulation system ensures that all relevant information, such as product batches and event descriptions, is documented and shared with all relevant parties.

  • Client Adherence
We assist in monitoring client needs, identifying potential areas for improvement, launching high-quality inquiries, and drawing satisfactory conclusions.

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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