Non-Clinical Overview & Clinical Overview

Ensure Regulatory Confidence by Delivering Comprehensive, High-quality Non-Clinical and Clinical Overviews

We offer precise and expert non-clinical and clinical overview services to support your regulatory submissions with precision.

Zenovel’s expertise in developing Clinical Overviews (Module 2.5) and Non-Clinical (Module 2.4) ensures that your regulatory filings meet the highest standards and are precise, comprehensive and compliant. Our services, which offer vital information and documentation for a variety of purposes, are intended to assist your drug development process.

Module 2.4 (Non-Clinical Overview Preparation) – Module 2.5 (Clinical Overview Preparation) – Related Literature References (4.3 & 5.4) – Module 1.4.2 (CV & Signature of Non- Clinical Experts) – Module 1.4.3
(CV & Signature of Clinical
Experts)

Our team of experienced experts ensures that your overviews are prepared with the highest level of accuracy and detail.

We strictly follow all regulatory guidelines, guaranteeing that your submissions are fully compliant and prepared to the highest standards.

Our extensive experience in multiple therapeutic areas enables us to handle the complexities with expertise and confidence.

Provide high-quality documentation, ensure your projects are supported by comprehensive and dependable overviews.

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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.

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

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

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

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

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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Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

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Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Non-Clinical Overview & Clinical Overview

We offer precise and expert non-clinical and clinical overview services to support your regulatory submissions with precision.

Blogs and news

Our Latest Article

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

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

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

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Ensuring Data Integrity: Best Practices and Considerations

Enhancing Clinical Studies with GCP Audit and Monitoring

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