Ensuring Compliance and Enhance Safety throughout your product Life Cycle
After receiving Marketing Authorization approval, a medicinal product must adhere to additional regulatory requirements throughout its life-cycle to ensure compliance, sustained and successful use. Zenovel, a team of specialists with extensive experience in product Life-Cycle Management, is responsible for portfolio maintenance for large, medium-sized, and small pharmaceutical and biotech companies, offering assistance in all medicinal product life-cycle management needs in the EU, USA, and other countries. We offer a complete Life cycle management solutions with regulatory strategy and maintenance support
We ensure efficient management of a pharmaceutical product’s life cycle, from development to maturity, to maximize value, compliance, and patient safety. This involves setting objectives, developing detailed plans, and continuously monitoring progress to adapt to market and regulatory changes.
We adhere to all the regulatory laws such as UFDA, EMA, MHRA etc. by documentation, testing, monitoring, reporting adverse events, and ensuring manufacturing and marketing practices meet regulatory requirements, crucial for market approval and product presence, ensuring product safety.
We ensures accurate data presentation, thorough analysis, and regulatory alignment, facilitating approval processes, product monitoring, addressing queries, supporting lifecycle management, and promoting continuous improvement in pharmaceutical product
We conduct regular monitoring of product performance, regulatory updates, and process improvements.

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
We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
Copyright © 2024 Zenovel. All rights reserved.