Regulatory Intelligence Services

Providing Real-time Intelligence for Informed Regulatory Strategies and Data-driven Insights

We assist you to keep abreast with the always changing regulatory standards.

It can be a significant challengeof managing constantly evolving regulatory requirements, which vary across countries. Zenovel Regulatory Intelligence (RI) services provides entire platform for accessing global regulatory information, ensuring compliance and confidence in your operations.

In the highly regulated and fast-paced pharmaceutical sector, staying on top of trends is essential. Zenovel provides pharmaceutical firms with the necessary information to efficiently traverse the intricate regulatory landscape through its Regulatory Intelligence (RI) services. By ensuring that your pharmaceutical company adhere to international regulatory requirements, our complete RI services reduce risks and hasten market entrance.

Zenovel RI team focuses on providing accurate and relevant regulatory information for successful market entry. We address focused queries, provide an overview of targeted countries’ regulations, and assess regulatory needs before product registration, tailoring solution to meet the diverse needs of global pharmaceutical and biopharmaceutical companies.

Information gathering and data analysis

It involves the process of collecting data from various sources, staying updated on regulations, and analysing the information to understand its impact on products and strategies, assessing trends, potential regulatory hurdles, and opportunities.

Strategic planning and Risk Management Approaches

It involves analysing regulatory strategies, planning product development, submissions, and post-approval activities to ensure compliance. Further, with the help of risk management process we identify and mitigate risks, anticipate challenges, and develop contingency plans to prevent regulatory challenges.

Communication

It involves approach such as disseminating regulatory information and recommendations to internal stakeholders, coordinating strategies across R&D, clinical, and commercial teams for informed decision-making.

Compliance maintenance

It involves monitoring regulatory changes, updating labelling, safety reporting, and manufacturing practices to ensure on-going product compliance.

Competitive intelligence

It involves monitoring regulatory activities and competitor submissions to understand the competitive landscape and make necessary adjustments to strategies.

Training

Offer comprehensive training and updates on regulatory requirements and changes to ensure your team is well-informed about the implications for their work.

We ensure compliance with all legal criteria can significantly reduce the likelihood of delays or rejections in your process.

We have access to a robust information base for making well-informed judgments about product development and market entry.

We detect potential regulatory issues effective preventative management and mitigation.

We stay updated with regulatory strategies and potential market trends of your competitors.

We focus on areas where regulations have the most significant impact on efficient resource allocation.

Reach out to us for any inquiries or support needs.

Blogs and news

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

Regulatory Intelligence Services

We assist you to keep abreast with the always changing regulatory standards.

Information gathering and data analysis

Strategic planning and Risk Management Approaches

Communication

Compliance maintenance

Competitive intelligence

Training

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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