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.
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: