Your trustworthy partner in navigating concept to market with leading expertise
At zenovel, we provide an array of professional services designed to assist the biotechnology and pharmaceutical sectors at every stage of growth. our interdisciplinary approach ensures that your projects benefit from cutting-edge solutions and integrated expertise.
Our team of professionals, with extensive knowledge and experience across various sectors, guarantees specialized and well- informed answers.
Cover IT solutions, preclinical support, CMC development, and intellectual property protection, offering a comprehensive one- stop solution for all your needs.
We utilize cutting-edge tools and techniques to provide innovative solutions that enhance productivity, regulatory compliance, and overall project success.
Our track record of assisting clients in achieving their strategic and operational objectives, from early-stage development to market launch, is extensive.
Our international network provides global insights and solutions to support your projects’ success in key global markets.
Guarantee that your projects comply with all necessary guidelines and regulations, upholding the highest standards of regulatory compliance.
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