Guideline Summaries
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:
Background and Development The ICH E6(R3) guideline was developed following extensive public consultation that began in May 2023, where over 7,000 comments were received and analyzed. This revision is rooted in the foundational principles of Quality by Design (QbD) and emphasizes a proportionate, risk-based approach to clinical trial conduct. The
The FDA’s Generic Drug User Fee Amendments (GDUFA III) are designed to enhance the review process for ANDAs (Abbreviated New Drug Applications), ensuring faster, more efficient access to affordable medications. Here’s what you need to know: Purpose: Provides guidance on how amendments to ANDAs (Abbreviated New Drug Applications) or PASs
Introduction: PSG meetings are crucial touchpoints between the FDA and ANDA applicants, designed to ensure your bioequivalence (BE) studies align with the latest regulatory requirements. These meetings help streamline the approval process by providing clear guidance on BE study designs, enabling compliance with FDA standards, and reducing potential roadblocks in
Introduction: The ICH Q14 Draft Guideline on Analytical Procedure Development, endorsed on March 24, 2022, outlines a science and risk-based framework for developing and maintaining analytical procedures essential for evaluating the quality of drug substances and products. This document is currently under public consultation as part of the ICH process.
The FDA has finalized a significant rule aimed at establishing requirements for nonprescription drug products that include an Additional Condition for Nonprescription Use (ACNU). This initiative is designed to enhance consumer access to safe and effective medications while ensuring that individuals can self-select and use these products without the need
The M13A Bioequivalence Guidance for Immediate-Release Solid Oral Dosage Forms, issued by the FDA, provides comprehensive recommendations for conducting bioequivalence (BE) studies. Here’s a summary of the key points from the guideline: Introduction: Objective: The guideline aims to offer recommendations for BE studies during both development and post-approval phases for
