Every feather in our crown is evidence of Zenovel’s Commitment, Proficiency, and Relentess Search towards Excellence
In 2023, Zenovel proudly completed 332 Audit Days, strengthening trust with over 50 clients and delivering 103 high-quality Audit Reports. 🏆
Our global footprint extends across major markets, including India, China, and the USA, navigating regulatory scrutiny from the USFDA and EMA. 🌐
We maintained the highest GMP standards across all operations, from APIs to Finished Formulations, ensuring excellence in Plant Set-ups, QMS Upgrades, and more.
In 2023, Zenovel embarked on a transformative journey, achieving remarkable milestones in clinical research organization. Conducting 210 global studies, we continued to push boundaries with cutting-edge methodologies.
Our dedication to Data Integrity, Electronic Compliance and Diverse Pre-Clinical Studies sets us apart as leaders in the field.
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