Life Cycle Management Services
Ensuring Compliance and Enhance Safety throughout your product Life Cycle
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.
The European Union’s Good Manufacturing Practice (GMP) standards, as outlined in the Annex to the Guide to Good Manufacturing Practice for Medicinal Products, ensure the quality and safety of medicinal products, including those used in clinical trials. The Qualified Person (QP) plays a crucial role in batch certification, particularly for
In the intricate process of developing new pharmaceuticals, guaranteeing product safety, effectiveness, and adherence to global regulations is essential. Batch release testing acts as a pivotal quality assurance measure, confirming that medications comply with rigorous criteria before distribution. When combined with International Council for Harmonisation (ICH) standards, this testing framework
In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
