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GMP Audit Services

Reliable Audit Solutions to Ensure Global Compliance and Safeguard Your Supply Chain

We can meet all of your supply-chain auditing needs.

We are reputable provider of 17 years of experience in GMP audits to ensure products meet industry standards and quality standards. Our experienced team conducts GMP audits globally, assessing a pharma company’s control over processes, facilities, and QMS, including API, intermediates, raw materials, warehouses, and packaging facilities. Trust Zenovel for reliable GMP audits that help maintain excellence in pharmaceutical manufacturing.

  • Third Party Audit Services

We conducts third-party GMP audits using experienced auditors to assess a supplier’s compliance with regulatory standards, including detailed documentation review, on-site inspections, staff interviews, and comprehensive reporting to ensure adherence to Good Manufacturing Practice guidelines.

We can meet all of your supply-chain auditing needs.

We proactively assist in alleviating audit burdens

We understand the demands and constraints placed on pharmaceutical firms, as well as the pressure their suppliers face from audits. This inspired us to develop a strategy that benefits all stakeholders while offering a premium audit service.

Our framework provides elite audit services tailored to the demands of pharmaceutical firms’ effectively addressing challenges in supplier auditing. We prioritize adherence to standards, regulations, and impartiality, avoiding conflicts of interest and supplier-customer interactions.

  • Our Audit Framework

We streamline auditing process by identifying top-tier auditing firms and auditors, coordinating all stakeholders to align audit schedule with auditor and sponsor timelines.

Upon contract agreement, we promptly initiate audit planning, scheduling audit days based on the auditor and sponsors deadlines. After scheduling, the company seeks competent auditors and qualified teams to effectively handle and execute the audit.

Utilize our complete audit life cycle management services to streamline your supplier audit, covering planning, execution, reporting, and CAPA follow up, allowing you to efficiently manage and conclude audits for your suppliers. From here we take care of audit from beginning to the end.

  • Joint Audit
We conducts third-party GMP audits using experienced auditors to assess a supplier’s compliance with regulatory standards, including detailed documentation review, on-site inspections, staff interviews, and comprehensive reporting to ensure adherence to Good Manufacturing Practice guidelines.

We aim to offer the most feasible choice, providing shared costs and tailored reports at the best possible price for you

We provide Joint Audit Services, a collaborative auditing method where multiple parties collaborate. This approach ensures comprehensive assessments, optimizes efficiency, reduces duplication, and enhances transparency. It leads to improved compliance and quality. Trust Zenovel for expertly managed joint audit services, fostering cooperation and driving excellence in regulatory compliance.

  • What can you anticipate from our All-in-One,
    Zenovel Solution?
  • Why Choose Zenovel ?
  • Audit Spectrum

We are qualified to audit a wide range of international manufacturers of pharmaceutical drugs and to all applicable regional and global compliance requirements.

  • Unanimity

Auditors maintain a high level of impartiality in their evaluations, assessing sponsors’ specific requirements and communicating them to the auditors using unbiased standards

  • Maintaining Confidentiality

The audit sponsors, auditors, and sponsors are all subjected to strict confidentiality conditions, including through NDAs or CDAs, to ensure the integrity of all information.

  • No Competing Interest

The EMA guidelines mandate that auditors and sponsors must have no commercial connections, which auditors thoroughly examine during the audit process to ensure regulatory compliance.

  • Tailored Reports

Each sponsor receives a detailed report tailored to their interests and specific updates based on their criteria.

  • Global Services

We offer global audit services with native auditors, ensuring comprehensive coverage and adherence to international standards in any country.

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.

Read More
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

Read More
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

Read More
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

Read More
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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