White Papers
Testament to Excellence, Recent Service Advancements and Cutting-Edge Innovation
Testament to Excellence, Recent Service Advancements and Cutting-Edge Innovation
Each white paper provides a thorough analysis of our services and offers deep insights into how they might transform the pharmaceutical and clinical environments. We empower stakeholders by providing practical guidance on medication development and regulatory compliance; ensuring treatments meet the highest efficacy and safety criteria in clinical settings.
India is a significant player in the global pharmaceuticals sector, characterized by a diverse population and cost-effective infrastructure. However, its potential in clinical research is hindered by complex regulatory challenges that delay innovations and deter investment, affecting the timely market introduction of life-saving drugs. This blog discusses the major obstacles
The FDA issued 466 Form 483s to drug organizations in FY 2022, more than double the previous year, highlighting significant quality failures in the pharmaceutical sector. For startups and scale-ups seeking market approval, the excitement of innovation often conflicts with the strict requirements of current good manufacturing practices (cGMP). Although
In the pharmaceutical and biotechnology industries, obtaining regulatory approval is essential prior to introducing new drugs or biologics to the market. A pivotal aspect of this approval process is the FDA Pre-Approval Inspection (PAI), which involves a comprehensive assessment of manufacturing facilities, processes, and data integrity to ensure adherence to
Risk Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data,
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 Certification) is
ABSTRACT: There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect
ABSTRACT: Clinical trials in today’s world are an expensive, complex multi-disciplinary process involving multiple stakeholders working together to comply with stringent regulations to improve patient lives by bringing innovative therapy to the market. There are multiple ways to achieve quality and compliance in clinical trials, but still, many CROs are
ABSTRACT: For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes.Regulatory guidance like ICH, and FDA encourage sponsors to adopt advancedconcepts
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