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Pre-Inspection Readiness

Master Compliance with our Mock Inspections for Your Seamless Pre-inspection Readiness

We ensure excellence in compliance by offering our pre-inspection readiness services.

The pharmaceutical manufacturing industry requires rigorous audit and inspection readiness to ensure compliance with quality standards. These inspections are crucial for ensuring the quality and safety of pharmaceutical products. Therefore, pharmaceutical companies must approach these inspections with careful planning, attention to detail, and a proactive mind-set.

Zenovel acknowledges the demanding and time-consuming nature of preparing for audit and inspection. Our team of professionals offers comprehensive simulated inspection services to help prepare your facility for US-FDA, EMA, and MHRA inspection. We conducts audit or mock inspection, review your documentations and quality systems, validate your process, and provide valuable feedback on areas for improvement.

To effectively prepare, first acquaint yourself with the inspection procedure. The following phases are involved:

  • Inspection

The FDA field inspector’s conducts inspection at facilities, reviewing records, interviewing personnel, and assessing compliance with regulations.

  • Reporting

The FDA releases an inspection report outlining any observations or conclusions.

  • Notification

The FDA informs pharmaceutical company of an upcoming inspection, which can be given as little as five days or weeks in advance, even sometimes a surprised visit happens

  • Preparation

Pharmaceutical company should conduct a comprehensive self-assessment, evaluate all SOP’s and regulatory documentation, and thoroughly examine processes to ensure easy accessibility of all relevant material.

  • What you expect from Zenovel Consulting Services?
  • We help you to prepare you for inspection ready in best possible way:

To pass an FDA inspection, a proactive, risk-based strategy is necessary for effective quality system, process, and regulatory adherence, requiring crucial preparatory actions.

  • MOCK INSPECTION

We transmit you with GMP mock inspection assistance to ensure process readiness.

The implementation of internal mock inspections can identify readiness gaps, familiarize staff with the inspection procedure, and offer practical experience in handling inquiries. Our mock inspection readiness services offers simulate real inspection scenarios, reviewing processes, quality management system, documentation, and compliance levels. We identify gaps and provide targeted recommendations, ensuring your team is well-prepared for regulatory audits, reducing non-compliance risks, and enhancing inspection outcomes.

  • Our proactive approach to assist you in GMP inspection through mock inspection
  • Why Choose Zenovel ?
  • Effective Inspection Management
  • Identifying and rectifying non-compliant processes, ensuring robust quality control systems.
  • Preparing employees for roles, along with anticipating inspection scenarios and providing comprehensive training.
  • Well Trained Personnel
  • We offer effective personnel for operations and compliance, ensuring smooth processes, maintaining high quality standards.
  • Handling inspections and audits with confidence and competence.
  • Well Prepared
  • Our preparation is vital for operational excellence and regulatory compliance.
  • Thorough planning, staff training, and proactive identification of potential issues to ensure confident and effective handling of inspections and audits.
  • Favourable First Impression
  • We believe in establishing trust and credibility requires presenting a well-organized, professional, and compliant operation from the start, ensuring inspectors and stakeholders recognize your commitment to excellence and regulatory adherence.

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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
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  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
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  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
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  • 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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