We Embody a Legacy of Incredible Discoveries, Exploring the Boundaries of Innovation and Science
At Zenovel, we integrate our extensive expertise across a wide range of domains, from Good Clinical Practice to Regulatory Affairs, to present valuable insights and thought leadership. Each blog reflects our intense dedication to innovation, offering a forum to share our perspectives, groundbreaking ideas, and industry expertise. Through our blogs, we hope to uplift, inform, and support scientific, medical, and pharmaceutical innovation.
In the world of globalized pharmaceutical industry, clinical trials and regulatory affairs are becoming ever more international in terms of
The Indian pharmaceutical industry, a global leader and the third-largest medicine producer by volume, is renowned for providing cost-effective, high-quality
Steps to Optimize Your Regulatory Affairs Process Regulatory affairs professionals in medical technology are crucial in ensuring compliance and market
In the fast-paced and highly regulated world of pharmaceuticals and nutraceuticals, following Good Manufacturing Practices (GMP) is vital for assuring
Drug discovery to market approval is a lengthy and arduous endeavor, lasting a year or more while taking an enormous
Clinical trials are obviously the spine of medical innovation, but their success defines through constant and stringent oversight process compliance
Ensuring Quality and Compliance in Manufacturing by GMP audits Good Manufacturing Practice (GMP) audits are crucial in the pharmaceutical, biotechnology, and medical device industries for product safety, consistency, and regulatory compliance. A good GMP audit can evaluate an organization’s adherence to quality standards, identify improvement areas, and ensure products meet
In the ever- changing pharmaceutical sector, studies of bioavailability (BA) and bioequivalence (BE) are essential to the approval of both name-brand and generic medications. BA and BE have grown in significance during the last thirty years, becoming essential for guaranteeing the safety and therapeutic effectiveness of pharmaceutical goods. Since these
Good Manufacturing Practices Audit: At Zenovel, we prioritizes maintaining high quality standards in the pharmaceutical supply chain through GMP audits, ensuring compliance with health authority regulations, industry best practices, and current standards. As regulatory requirements evolve, there’s a growing need for enhanced vigilance and Quality Risk Management during the audit
Overview of Regulatory Oversight in Life Sciences and Pharmaceutical Companies Regulatory agencies including the FDA, EMA, PMDA, HPRA, CDSCO, and others keep a vigilant eye on the life sciences and pharmaceutical sector. These organisations are committed to safeguarding patient safety and drug-product quality. In fiscal year 2023, the FDA
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
