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Blockages can be Solved by the Right Answer
Blockages can be Solved by the Right Answer
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Pharmacovigilance (PV), the scientific process of detection, assessment, understanding, and prevention of adverse drug reactions, is going to be revolutionized in 2025. PV is evolving from a more reactive to a proactive discipline, aided by new and evolving technologies, including quantum-enhanced AI, global safety monitoring in real time, and other
In the world of globalized pharmaceutical industry, clinical trials and regulatory affairs are becoming ever more international in terms of languages and cultures. India is well on the way to becoming a global pharmaceutical hub in 2025, now is the time to ensure that we get accurate translation and localization
The Indian pharmaceutical industry, a global leader and the third-largest medicine producer by volume, is renowned for providing cost-effective, high-quality drugs worldwide. In 2025, new regulatory frameworks and stringent compliance requirements are being implemented, compelling Indian pharma companies to adapt. These reforms aim to enhance credibility, safety, and global competitiveness,
Steps to Optimize Your Regulatory Affairs Process Regulatory affairs professionals in medical technology are crucial in ensuring compliance and market entry. Such professionals face challenges in navigating registration processes, fostering collaboration, and utilizing data-driven insights. Innovative regulatory solutions can enhance efficiency and improve outcomes. This blog presents five transformative strategies
In the fast-paced and highly regulated world of pharmaceuticals and nutraceuticals, following Good Manufacturing Practices (GMP) is vital for assuring safety, quality, and regulatory compliance. Dealing with the intricacies of GMP standards can be overwhelming, requiring extensive technical knowledge and strategic assistance. A reliable GMP consultants can provide valuable assistance.
Drug discovery to market approval is a lengthy and arduous endeavor, lasting a year or more while taking an enormous amount of resources and finances. Among the various processes in going from discovery to market, Chemistry, Manufacturing, and Controls (CMC) is essential in establishing that drugs are safe and effective
Phase 3 clinical trials are crucial for confirming the safety and efficacy of a new treatment on a larger scale before it can be approved for widespread use. At Zenovel, we understand the critical role of Phase 3 trials in bringing safe and effective treatments to market. By leveraging our
Introduction Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. The questions below are designed to help understand what OTC medications are, their uses, and important considerations when using them. What are Over-the-Counter (OTC) Drugs? Over-the-Counter
Introduction The new regulations established by the FDA for nonprescription drug products that include an additional condition for nonprescription use (ACNU) are designed to enhance consumer access to safe and effective medications while ensuring proper self-selection and usage without the need for a prescription. What is a nonprescription drug product
Introduction The ICH Q14 Guideline is an international guideline that outlines science and risk-based approaches for developing and maintaining analytical procedures used to evaluate the quality of drug substances and products. It ensures that analytical methods are fit for their intended purpose and focuses on both traditional and enhanced development
Introduction Navigating the complexities of GxP regulations can be challenging. This FAQ section provides valuable insights into common questions related to GxP compliance, including the consequences of non-compliance, the importance of a robust Quality Management System (QMS), and a deeper dive into Good Clinical Practice (GCP) and Good Manufacturing Practice
Phase 3 clinical trials are crucial for confirming the safety and efficacy of a new treatment on a larger scale before it can be approved for widespread use. At Zenovel, we understand the critical role of Phase 3 trials in bringing safe and effective treatments to market. By leveraging our
