Guideline Summaries
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
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
