CRO Setup and upgradation services
Transform and Upgrades Your CRO with Our GCP Setup, and Custom Compliance Strategies
Transform and Upgrades Your CRO with Our GCP Setup, and Custom Compliance Strategies
With extensive experience in auditing and monitoring CROs across more than 30 countries, Zenovel offers expert services for CRO setup and upgradation, leveraging industry knowledge and global insights to optimize partnerships, ensuring efficiency, compliance, and excellence in clinical research endeavours.
For the CRO upgradation initiative, Zenovel focuses on enhancing the capabilities of the existing facility to perform a wide range of clinical studies across all therapeutic areas, with the ultimate goal of achieving regulatory approvals for submission into major global markets such as USFDA, EMEA, MHRA, WHO, TGA, ANVISA, and others.
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
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