Life Cycle Management Services

Ensuring Compliance and Enhance Safety throughout your product Life Cycle

We assist you in regulatory action and post-approval support throughout the product life cycle to guarantee safety, compliance, and best practices in product maintenance

After receiving Marketing Authorization approval, a medicinal product must adhere to additional regulatory requirements throughout its life-cycle to ensure compliance, sustained and successful use. Zenovel, a team of specialists with extensive experience in product Life-Cycle Management, is responsible for portfolio maintenance for large, medium-sized, and small pharmaceutical and biotech companies, offering assistance in all medicinal product life-cycle management needs in the EU, USA, and other countries. We offer a complete Life cycle management solutions with regulatory strategy and maintenance support

We ensure efficient management of a pharmaceutical product’s life cycle, from development to maturity, to maximize value, compliance, and patient safety. This involves setting objectives, developing detailed plans, and continuously monitoring progress to adapt to market and regulatory changes.

We adhere to all the regulatory laws such as UFDA, EMA, MHRA etc. by documentation, testing, monitoring, reporting adverse events, and ensuring manufacturing and marketing practices meet regulatory requirements, crucial for market approval and product presence, ensuring product safety.

We ensures accurate data presentation, thorough analysis, and regulatory alignment, facilitating approval processes, product monitoring, addressing queries, supporting lifecycle management, and promoting continuous improvement in pharmaceutical product

We conduct regular monitoring of product performance, regulatory updates, and process improvements.

Reach out to us for any inquiries or support needs.

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Our Latest Article

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

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

Life Cycle Management Services

We assist you in regulatory action and post-approval support throughout the product life cycle to guarantee safety, compliance, and best practices in product maintenance

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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