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Blockages can be Solved by the Right Answer
Blockages can be Solved by the Right Answer
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Welcome to the Zenovel Blog! We are a leading provider of drug regulatory consulting and education, focusing on advancing pharmaceutical innovation while ensuring safety and compliance. This blog delves into the essentials of Drug Regulatory Affairs (DRA), covering its scope, career opportunities, and intricate processes involved in bringing new drugs
The international pharmaceutical landscape is inherently connected to the global economy and global trade, which is consisted with the quality and safety assurance , well-controlled quality and safety. Compliance with international pharmaceutical standards has changed from an optional step to a requirement. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the
Lipinski’s Rule of 5 (Ro5) is a crucial guideline in pharmaceutical development, helping researchers evaluate a compound’s likelihood of becoming an effective oral drug. However, with the rapid evolution of therapeutic strategies, it’s worth considering the relevance of Ro5 in the current drug design landscape. Understanding Lipinski’s Rule of 5
Regulatory affairs (RA) play a crucial role in the pharmaceutical industry; ensuring products meet quality, safety, and efficacy. As the industry grow further the need for qualified professionals to bridge gaps between companies and regulators increases. This blog explores Zenovel regulatory affairs expertise, our various facets, and valuable contribution to
Navigating the world of pharmaceuticals, medical devices, and biotechnology is never straightforward. With the diversity of regulatory compliance governs the Code of Federal Regulations (CFR) – a regulatory path that shapes companies’ efforts and implements how companies long for their products to be developed, manufactured, and marketed. For companies trying
The race to deliver life-saving therapies to patients is increasingly faster and more complex. Pharmaceutical and biotech companies are faced with a dizzying list of challenges — global clinical trials, continuously changing regulations, multiple complicated therapeutic areas, and pressure to innovate. This is where Contract Research Organizations (CRO) come in:
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
