Dossier out-licensing services

Unlock New Markets and Ensure Sustainable Growth in Pharmaceuticals with Our Future-Focused Out-licensing Solutions

We empower your growth by our seamless out-licensing services

We provide comprehensive preparation, market analysis, regulatory compliance, and on-going support for partners to successfully commercialize products in new markets through seamless transfer of documentation and knowledge.

Out-licensing services is a process of granting another company the rights to a pharmaceutical product’s regulatory documents for commercialization for a dossier. Zenovel provides specialised dossier out-licensing services to help companies maximize the value of their products, which facilitate the seamless transfer of regulatory expertise and paperwork, as well as the identification of potential partners.

Through Out-licensing, we can enable your products to attain their maximum potential and contribute to global well-being. We, therefore assist you to search for complimentary, win-win alliances while keeping an eye on the future.

We help identify complementary, win-win alliances, form strategic partnerships for growth, and monitor future opportunities.

We develop tailored strategies to meet the unique needs of your target market, ensuring your dossier adheres to all necessary compliance standards.

We ensure a smooth transfer of your dossier to the licensee and provide continuous support to ensure successful post-transfer and effective commercialization.

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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Dossier out-licensing services

We empower your growth by our seamless out-licensing services

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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