Streamline Your Market Entry with Expert Pre-Submission Support
We provides complete pre-submission services to help pharmaceutical manufacturers navigate the regulatory landscape and optimize their submissions for regulatory approval, ensuring a successful outcome for pharmaceutical, biologic, medical device, or in-vitro diagnostic products.
Engaging in pre-submission discussions such as FDA and other regulatory bodies is a crucial step in drug’s development, approval, commercialization, and medical device regulation. Pharmaceutical company should utilize this opportunity to present their products and regulatory plans to the FDA and health authorities, seeking their advice on the best course of action.
After reviewing an application, health authorities (HAs) may contact a sponsor or Marketing Authorization Holder (MAH) if the evidence is insufficient or further information is needed regarding efficacy, safety, and quality. This interaction underscores the proactive engagement with regulatory authorities.
Zenovel serves as a global regulatory partner for pharmaceutical companies, managing regulatory agency interactions and health authority meetings for drug development, approval, and post-approval changes. With a robust regulatory team of industry professionals and ex-agency experts, we support sponsors during agency meetings and ensure successful regulatory approval outcomes.
Enhance communication and collaboration between clients and regulatory authorities, promoting transparency, trust, and alignment throughout the submission process.
We help clients ensure your regulatory submissions meet all necessary standards and expectations, reducing the risk of non-compliance.
Tailoring regulatory strategies, navigating regulatory pathways, optimizing resource allocation, and enhancing efficiency of regulatory submission
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.
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
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
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
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
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